Trial Outcomes & Findings for Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy (NCT NCT00746395)
NCT ID: NCT00746395
Last Updated: 2020-10-08
Results Overview
Percent of subjects with capsule passage through small bowel
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
8 hours
Results posted on
2020-10-08
Participant Flow
Participants recruited from a specialty clinic in Mobile, AL, USA between April 2008 and September 2008.
45 participants recruited and screened, 1 excluded, 4 withdrew from study.
Participant milestones
| Measure |
Lubiprostone 24mcg Single Dose
lubiprostone 24mcg single dose po prior to capsule endoscopy
|
Sugar Pill
Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy
Baseline characteristics by cohort
| Measure |
Lubiprostone 24mcg Single Dose
n=20 Participants
lubiprostone 24mcg single dose po prior to capsule endoscopy
|
Sugar Pill
n=20 Participants
Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
38.75 years
STANDARD_DEVIATION 13.15045 • n=99 Participants
|
35.4 years
STANDARD_DEVIATION 10.86472 • n=107 Participants
|
37.07 years
STANDARD_DEVIATION 2.36881 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: Placebo 95%, lubiprostone 75%
Percent of subjects with capsule passage through small bowel
Outcome measures
| Measure |
Lubiprostone 24mcg Single Dose
n=20 Participants
lubiprostone 24mcg single dose po prior to capsule endoscopy
|
Sugar Pill
n=20 Participants
Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
|
|---|---|---|
|
Complete Small Bowel Transit
|
75 percentage of subjects with passage
|
95 percentage of subjects with passage
|
SECONDARY outcome
Timeframe: Duration of the test - 8 hoursPopulation: Patients without transit to cecum were excluded
Small bowel transit time
Outcome measures
| Measure |
Lubiprostone 24mcg Single Dose
n=15 Participants
lubiprostone 24mcg single dose po prior to capsule endoscopy
|
Sugar Pill
n=19 Participants
Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
|
|---|---|---|
|
Small Bowel Transit
|
188.1 Minutes
Standard Error 68.0
|
218.9 Minutes
Standard Error 89.0
|
Adverse Events
Lubiprostone 24mcg Single Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lubiprostone 24mcg Single Dose
n=20 participants at risk
lubiprostone 24mcg single dose po prior to capsule endoscopy
|
Sugar Pill
n=20 participants at risk
Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
|
|---|---|---|
|
General disorders
Headache
|
5.0%
1/20 • Number of events 1 • From the administration of the drug through the end of the procedure.
No serious adverse events during study duration
|
5.0%
1/20 • Number of events 1 • From the administration of the drug through the end of the procedure.
No serious adverse events during study duration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place