Trial Outcomes & Findings for Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients (NCT NCT01533688)
NCT ID: NCT01533688
Last Updated: 2018-09-07
Results Overview
The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
212 participants
Primary outcome timeframe
Day 1
Results posted on
2018-09-07
Participant Flow
Participant milestones
| Measure |
Golytely + Placebo
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
|
Golytely Split + Placebo
split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
|
Golytely Split + Bisacodyl
split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg
split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
70
|
71
|
|
Overall Study
COMPLETED
|
63
|
60
|
63
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
8
|
Reasons for withdrawal
| Measure |
Golytely + Placebo
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
|
Golytely Split + Placebo
split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
|
Golytely Split + Bisacodyl
split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg
split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
3
|
|
Overall Study
Medically unstable
|
1
|
3
|
3
|
|
Overall Study
Had colonoscopy at outside hospital
|
2
|
3
|
2
|
Baseline Characteristics
Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients
Baseline characteristics by cohort
| Measure |
Golytely + Placebo
n=63 Participants
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
|
Golytely Split + Placebo
n=60 Participants
split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
|
Golytely Split + Bisacodyl
n=63 Participants
split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg
split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
62.8 years
STANDARD_DEVIATION 7.2 • n=107 Participants
|
63.2 years
STANDARD_DEVIATION 6.7 • n=206 Participants
|
63.5 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
178 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White race
|
41 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
137 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
22 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
63 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
186 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: We have missing data regarding reporting of Boston bowel preparation scores (BBPS), some providers didn't provide the BBPS and provided only subjective assessment of the bowel preparation (for example, good or excellent)
The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist.
Outcome measures
| Measure |
Golytely + Placebo
n=63 Participants
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
|
Golytely Split + Placebo
n=60 Participants
split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
|
Golytely Split + Bisacodyl
n=63 Participants
split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg
split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg
|
|---|---|---|---|
|
Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy.
|
42 Participants
|
50 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 24 hoursNumber of Participants Who Developed Side Effects of Taking Bowel Preparations
Outcome measures
| Measure |
Golytely + Placebo
n=63 Participants
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
|
Golytely Split + Placebo
n=60 Participants
split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
|
Golytely Split + Bisacodyl
n=63 Participants
split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg
split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg
|
|---|---|---|---|
|
Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.
|
24 Participants
|
28 Participants
|
28 Participants
|
Adverse Events
Golytely + Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Golytely Split + Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Golytely Split + Bisacodyl
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Golytely + Placebo
n=63 participants at risk
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
|
Golytely Split + Placebo
n=60 participants at risk
split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
|
Golytely Split + Bisacodyl
n=63 participants at risk
split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg
split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg
|
|---|---|---|---|
|
Gastrointestinal disorders
nausea and vomiting
|
9.5%
6/63
|
6.7%
4/60
|
9.5%
6/63
|
|
Gastrointestinal disorders
Bloating
|
15.9%
10/63
|
16.7%
10/60
|
15.9%
10/63
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
2/63
|
6.7%
4/60
|
3.2%
2/63
|
|
Gastrointestinal disorders
Rectal burning sensation
|
9.5%
6/63
|
15.0%
9/60
|
15.9%
10/63
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place