Trial Outcomes & Findings for A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy (NCT NCT03017235)
NCT ID: NCT03017235
Last Updated: 2018-11-14
Results Overview
The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
COMPLETED
PHASE3
917 participants
During colonoscopy procedure (5-9 hours after completed treatment)
2018-11-14
Participant Flow
Participant milestones
| Measure |
NaP/MC Oral Solution
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
Split dose regimen: Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.
|
PREPOPIK®
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject.
Split dose regimen :Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.
|
|---|---|---|
|
Overall Study
STARTED
|
456
|
461
|
|
Overall Study
COMPLETED
|
444
|
447
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
Reasons for withdrawal
| Measure |
NaP/MC Oral Solution
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
Split dose regimen: Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.
|
PREPOPIK®
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject.
Split dose regimen :Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Cancer, emergency, allergy, active UTI
|
4
|
2
|
Baseline Characteristics
A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
Baseline characteristics by cohort
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution: Supplied as ready-to-drink without further reconstitution before administration
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
Total
n=901 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.2 Years
STANDARD_DEVIATION 11.04 • n=99 Participants
|
57.1 Years
STANDARD_DEVIATION 10.85 • n=107 Participants
|
57.2 Years
STANDARD_DEVIATION 10.94 • n=206 Participants
|
|
Sex: Female, Male
Female
|
252 Participants
n=99 Participants
|
250 Participants
n=107 Participants
|
502 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
196 Participants
n=99 Participants
|
203 Participants
n=107 Participants
|
399 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
68 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
380 Participants
n=99 Participants
|
381 Participants
n=107 Participants
|
761 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
376 Participants
n=99 Participants
|
394 Participants
n=107 Participants
|
770 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Child-bearing potential
Child bearing potential
|
252 Participants
n=99 Participants
|
250 Participants
n=107 Participants
|
502 Participants
n=206 Participants
|
|
Child-bearing potential
Yes
|
49 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Child-bearing potential
No
|
203 Participants
n=99 Participants
|
203 Participants
n=107 Participants
|
406 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The primary efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"
|
87.7 Percentage of participants
Interval 84.3 to 90.6
|
81.5 Percentage of participants
Interval 77.6 to 84.9
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon
|
94.2 Percentage of subjects
Interval 91.6 to 96.2
|
89.6 Percentage of subjects
Interval 86.4 to 92.3
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon
|
96.0 Percentage of subjects
Interval 93.7 to 97.6
|
94.0 Percentage of subjects
Interval 91.4 to 96.0
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon
|
94.6 Percentage of subjects
Interval 92.1 to 96.5
|
91.2 Percentage of subjects
Interval 88.2 to 93.6
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
≤3/week
|
63 Participants
|
47 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
4 to 8/week
|
264 Participants
|
299 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
≥9/week
|
120 Participants
|
105 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
Response not provided
|
0 Participants
|
1 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
Not applicable
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
<25%
|
443 Participants
|
448 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
25% - 50%
|
1 Participants
|
1 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
50% - 75%
|
0 Participants
|
2 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
≥75%
|
1 Participants
|
0 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
Response not provided
|
2 Participants
|
1 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
Not applicable
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
Easy to acceptable
|
400 Participants
|
433 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
Somewhat difficult
|
41 Participants
|
17 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
Very difficult
|
4 Participants
|
1 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
Unacceptable
|
2 Participants
|
1 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
Not applicable
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
Somewhat willing
|
75 Participants
|
38 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
Not willing at all
|
11 Participants
|
6 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
Mostly willing
|
361 Participants
|
408 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
Not applicable
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
Yes
|
11 Participants
|
8 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
No
|
104 Participants
|
93 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
No difficulties
|
310 Participants
|
320 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
No health issues
|
84 Participants
|
109 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
Response not provided
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
Not bothered-Mildly bothered
|
371 Participants
|
426 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
Moderately bothered
|
63 Participants
|
22 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
Severely bothered
|
11 Participants
|
2 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
No response
|
1 Participants
|
3 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
Not applicable
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
Not bothered-Mildly bothered
|
382 Participants
|
387 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
Moderately bothered
|
53 Participants
|
57 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
Severely bothered
|
10 Participants
|
6 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
No response
|
2 Participants
|
3 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
Not applicable
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
Not bothered-Mildly bothered
|
335 Participants
|
328 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
Moderately bothered
|
86 Participants
|
85 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
Severely bothered
|
25 Participants
|
37 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
No response
|
1 Participants
|
3 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
Not applicable
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
Not bothered-Mildly bothered
|
416 Participants
|
435 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
Moderately bothered
|
23 Participants
|
11 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
Severely bothered
|
6 Participants
|
2 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
No response
|
2 Participants
|
4 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
Not applicable
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
Not bothered-Mildly bothered
|
403 Participants
|
402 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
Moderately bothered
|
35 Participants
|
40 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
Severely bothered
|
7 Participants
|
6 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
No response
|
2 Participants
|
4 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
Not applicable
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
Not bothered-Mildly bothered
|
427 Participants
|
432 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
Moderately bothered
|
15 Participants
|
15 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
Severely bothered
|
3 Participants
|
3 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
No response
|
1 Participants
|
2 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
Not applicable
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
Not bothered-Mildly bothered
|
396 Participants
|
396 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
Moderately bothered
|
38 Participants
|
47 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
Severely bothered
|
13 Participants
|
7 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
No response
|
0 Participants
|
2 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
Not applicable
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
No
|
261 Participants
|
281 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
Yes
|
185 Participants
|
171 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
Response not provided
|
1 Participants
|
2 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
Not applicable
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
GoLytely
|
56 Participants
|
52 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
Moviprep
|
14 Participants
|
17 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
MiraLax
|
20 Participants
|
20 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
Other
|
34 Participants
|
39 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
Do not remember
|
137 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedure (5-9 hours after completed treatment)Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
Better than before
|
190 Participants
|
209 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
Worse than before
|
5 Participants
|
5 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
About the same as before
|
62 Participants
|
67 Participants
|
|
Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
Response not provided
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline (screening) up to day 28 after colonoscopyPopulation: The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received
Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Percentage of Treatment-emergent Adverse Events(AEs)
|
84.4 Percentage of adverse events
|
84.8 Percentage of adverse events
|
SECONDARY outcome
Timeframe: From baseline (screening) up to day 28 after colonoscopyPopulation: The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received
Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Clinically Significant Changes in Vital Signs
Hypertension
|
0 Participants
|
4 Participants
|
|
Clinically Significant Changes in Vital Signs
Orthostatic hypotension
|
1 Participants
|
2 Participants
|
|
Clinically Significant Changes in Vital Signs
Blood pressure increased
|
2 Participants
|
0 Participants
|
|
Clinically Significant Changes in Vital Signs
Hypotension
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopyPopulation: The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received
Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Bradycardia
|
3 Participants
|
0 Participants
|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Bundle branch block left
|
0 Participants
|
2 Participants
|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Extrasystoles
|
0 Participants
|
2 Participants
|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Ventricular extrasystoles
|
2 Participants
|
0 Participants
|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Atrial fibrillation
|
1 Participants
|
0 Participants
|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Bundle branch block right
|
1 Participants
|
0 Participants
|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Palpitations
|
1 Participants
|
0 Participants
|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Sinus bradycardia
|
0 Participants
|
1 Participants
|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Tachycardia
|
0 Participants
|
1 Participants
|
|
Clinically Significant Changes in Electrocardiogram (ECG)
Cardiac murmur
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopyPopulation: The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received.
Rated by the investigator based on out of range laboratory values
Outcome measures
| Measure |
NaP/MC Oral Solution
n=448 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.
|
PREPOPIK®
n=453 Participants
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Clinically Significant Changes in Laboratory Values
Hematology: Anaemia
|
1 Participants
|
1 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry: Blood potassium decreased
|
1 Participants
|
0 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry: Hypochloraemia
|
0 Participants
|
1 Participants
|
|
Clinically Significant Changes in Laboratory Values
Hematology: Leukopenia
|
1 Participants
|
0 Participants
|
|
Clinically Significant Changes in Laboratory Values
Hematology: Lymphocytosis
|
0 Participants
|
1 Participants
|
|
Clinically Significant Changes in Laboratory Values
Hematology: Neutropenia
|
1 Participants
|
0 Participants
|
|
Clinically Significant Changes in Laboratory Values
Hematology: Normocytic anaemia
|
1 Participants
|
0 Participants
|
|
Clinically Significant Changes in Laboratory Values
Hemotology: Platelet count decreased
|
0 Participants
|
1 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical Chemistry: Hypermagnesaemia
|
9 Participants
|
23 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry:Blood bicarbonate decreased
|
6 Participants
|
3 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry: Hypokalemia
|
4 Participants
|
0 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry: Hyperglycaemia
|
2 Participants
|
1 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry: Hypoglycaemia
|
3 Participants
|
0 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry: Hyperkalaemia
|
0 Participants
|
2 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry: Hypomagnasaemia
|
2 Participants
|
0 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry: Blood creatinine increased
|
0 Participants
|
1 Participants
|
|
Clinically Significant Changes in Laboratory Values
Clinical chemistry: Hyperbilirubinaemia
|
0 Participants
|
1 Participants
|
|
Clinically Significant Changes in Laboratory Values
Urinalysis
|
0 Participants
|
0 Participants
|
Adverse Events
NaP/MC Oral Solution
PREPOPIK®
Serious adverse events
| Measure |
NaP/MC Oral Solution
n=448 participants at risk
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles per subject without further reconstitution before administration.
|
PREPOPIK®
n=453 participants at risk
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder
Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.22%
1/448 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
0.00%
0/453 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Gastrointestinal disorders
Ascites
|
0.22%
1/448 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
0.00%
0/453 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/448 • From baseline (screening) upto 28 days after colonoscopy.
|
0.22%
1/453 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Infections and infestations
Influenza
|
0.00%
0/448 • From baseline (screening) upto 28 days after colonoscopy.
|
0.22%
1/453 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.22%
1/448 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
0.00%
0/453 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.89%
4/448 • Number of events 4 • From baseline (screening) upto 28 days after colonoscopy.
|
0.00%
0/453 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.45%
2/448 • Number of events 2 • From baseline (screening) upto 28 days after colonoscopy.
|
0.22%
1/453 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/448 • From baseline (screening) upto 28 days after colonoscopy.
|
0.22%
1/453 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.22%
1/448 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
0.00%
0/453 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.00%
0/448 • From baseline (screening) upto 28 days after colonoscopy.
|
0.22%
1/453 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/448 • From baseline (screening) upto 28 days after colonoscopy.
|
0.22%
1/453 • Number of events 1 • From baseline (screening) upto 28 days after colonoscopy.
|
Other adverse events
| Measure |
NaP/MC Oral Solution
n=448 participants at risk
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Supplied as two 160 mL ready-to-drink bottles per subject without further reconstitution before administration.
|
PREPOPIK®
n=453 participants at risk
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder
Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
|
|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
33.5%
150/448 • Number of events 162 • From baseline (screening) upto 28 days after colonoscopy.
|
34.2%
155/453 • Number of events 167 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Gastrointestinal disorders
Large intestine polyp
|
20.8%
93/448 • Number of events 157 • From baseline (screening) upto 28 days after colonoscopy.
|
23.2%
105/453 • Number of events 181 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
15.6%
70/448 • Number of events 75 • From baseline (screening) upto 28 days after colonoscopy.
|
15.5%
70/453 • Number of events 73 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Gastrointestinal disorders
Diverticulum
|
14.3%
64/448 • Number of events 64 • From baseline (screening) upto 28 days after colonoscopy.
|
13.0%
59/453 • Number of events 59 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Infections and infestations
Investigations
|
5.6%
25/448 • Number of events 26 • From baseline (screening) upto 28 days after colonoscopy.
|
5.1%
23/453 • Number of events 26 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.0%
9/448 • Number of events 9 • From baseline (screening) upto 28 days after colonoscopy.
|
5.1%
23/453 • Number of events 26 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
29.7%
133/448 • Number of events 237 • From baseline (screening) upto 28 days after colonoscopy.
|
28.3%
128/453 • Number of events 211 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Infections and infestations
Infections and infestations
|
6.0%
27/448 • Number of events 29 • From baseline (screening) upto 28 days after colonoscopy.
|
7.7%
35/453 • Number of events 35 • From baseline (screening) upto 28 days after colonoscopy.
|
|
Nervous system disorders
Nervous system disorders
|
6.0%
27/448 • Number of events 27 • From baseline (screening) upto 28 days after colonoscopy.
|
6.6%
30/453 • Number of events 34 • From baseline (screening) upto 28 days after colonoscopy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER