Trial Outcomes & Findings for Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy (NCT NCT02123017)
NCT ID: NCT02123017
Last Updated: 2016-02-24
Results Overview
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
10-14 hours post last consumption
Results posted on
2016-02-24
Participant Flow
Participant milestones
| Measure |
90 Grams Crystalline Lactulose
15 mg bisacodyl, plus 30 grams crystalline lactulose x 3 doses
|
135 Grams Crystalline Lactulose
15 mg bisacodyl, plus 45 grams crystalline lactulose x 3 doses
|
180 Grams Crystalline Lactulose
15 mg bisacodyl, plus 60 grams crystalline lactulose x 3 doses
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
12
|
|
Overall Study
COMPLETED
|
8
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy
Baseline characteristics by cohort
| Measure |
90 Grams of Crystalline Lactulose
n=8 Participants
15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
|
135 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
|
180 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Subject Age at Enrollment
|
47.4 years
STANDARD_DEVIATION 6.2 • n=93 Participants
|
57.0 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
58.1 years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
55.0 years
STANDARD_DEVIATION 8.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 10-14 hours post last consumptionEfficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
Outcome measures
| Measure |
90 Grams of Crystalline Lactulose
n=7 Participants
15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
|
135 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
|
180 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
|
|---|---|---|---|
|
Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
|
5.7 units on a scale
Standard Deviation 2.8
|
7.4 units on a scale
Standard Deviation 0.9
|
7.8 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 1 day post last consumptionSafety determined by the incidence of treatment emergent adverse events.
Outcome measures
| Measure |
90 Grams of Crystalline Lactulose
n=8 Participants
15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
|
135 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
|
180 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
|
|---|---|---|---|
|
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence
|
25 % of patients with adverse events
|
33 % of patients with adverse events
|
50 % of patients with adverse events
|
SECONDARY outcome
Timeframe: 1 day post last consumptionSafety determined by the severity of treatment emergent adverse events.
Outcome measures
| Measure |
90 Grams of Crystalline Lactulose
n=8 Participants
15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
|
135 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
|
180 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
|
|---|---|---|---|
|
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
Severe
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
|
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
Mild
|
0 Percentage of subjects
|
25 Percentage of subjects
|
50 Percentage of subjects
|
|
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
Moderate
|
25 Percentage of subjects
|
8 Percentage of subjects
|
0 Percentage of subjects
|
SECONDARY outcome
Timeframe: 1 day post last consumptionTolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable
Outcome measures
| Measure |
90 Grams of Crystalline Lactulose
n=8 Participants
15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
|
135 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
|
180 Grams of Crystalline Lactulose
n=12 Participants
15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
|
|---|---|---|---|
|
Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant
|
65.4 units on a VAS scale
Standard Deviation 27.6
|
68.5 units on a VAS scale
Standard Deviation 19.6
|
71.3 units on a VAS scale
Standard Deviation 18.4
|
Adverse Events
90 Grams of Crystalline Lactulose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
135 Grams of Crystalline Lactulose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
180 Grams of Crystalline Lactulose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
90 Grams of Crystalline Lactulose
n=8 participants at risk
15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
|
135 Grams of Crystalline Lactulose
n=12 participants at risk
15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
|
180 Grams of Crystalline Lactulose
n=12 participants at risk
15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/8 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
8.3%
1/12 • Number of events 1 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
0.00%
0/12 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
8.3%
1/12 • Number of events 1 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
0.00%
0/12 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 2 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
16.7%
2/12 • Number of events 2 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
0.00%
0/12 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
|
Vascular disorders
Procedural hypotension
|
0.00%
0/8 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
33.3%
4/12 • Number of events 4 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
50.0%
6/12 • Number of events 6 • Adverse Events were collected from the first dose of study drug through the end of the observation period after the colonoscopy (Day 2).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place