Trial Outcomes & Findings for F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects (NCT NCT00857272)
NCT ID: NCT00857272
Last Updated: 2010-10-05
Results Overview
Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = "excellent" (no more than small bits of adherent feces/fluid); 3 = "good" (small amounts of feces or fluid not interfering with the exam); 2 = "fair" (enough feces or fluid to prevent a completely reliable exam); 1 = "poor" (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a "success" and grades of 2 or 1 were considered a "failure".
COMPLETED
PHASE4
308 participants
during colonoscopy
2010-10-05
Participant Flow
Participant milestones
| Measure |
HalfLytely With 5mg Bisacodyl
Investigational dose
|
HalfLytely With 10mg Bisacodyl
Active Control
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
154
|
|
Overall Study
COMPLETED
|
145
|
145
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Baseline characteristics by cohort
| Measure |
HalfLytely With 5mg Bisacodyl
n=154 Participants
Investigational dose
|
HalfLytely With 10mg Bisacodyl
n=154 Participants
Active Control
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
110 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age Continuous
|
56.8 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
55.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=5 Participants
|
154 participants
n=7 Participants
|
308 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during colonoscopyPopulation: The analysis population consists of patients that were randomized and took any portion of the study preparation and who did not discontinue prior to colonoscopy due to a reason of safety or efficacy.
Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = "excellent" (no more than small bits of adherent feces/fluid); 3 = "good" (small amounts of feces or fluid not interfering with the exam); 2 = "fair" (enough feces or fluid to prevent a completely reliable exam); 1 = "poor" (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a "success" and grades of 2 or 1 were considered a "failure".
Outcome measures
| Measure |
HalfLytely With 5mg Bisacodyl
n=147 Participants
Investigational dose
|
HalfLytely With 10mg Bisacodyl
n=146 Participants
Active Control
|
|---|---|---|
|
Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
|
77.6 percent of participants
Interval 69.9 to 84.0
|
80.1 percent of participants
Interval 72.7 to 86.3
|
Adverse Events
HalfLytely With 5mg Bisacodyl
HalfLytely With 10mg Bisacodyl
Serious adverse events
| Measure |
HalfLytely With 5mg Bisacodyl
n=154 participants at risk
Investigational dose
|
HalfLytely With 10mg Bisacodyl
n=154 participants at risk
Active Control
|
|---|---|---|
|
Infections and infestations
urinary tract infection
|
0.00%
0/154
|
0.65%
1/154 • Number of events 1
|
|
Infections and infestations
urosepsis
|
0.00%
0/154
|
0.65%
1/154 • Number of events 1
|
Other adverse events
| Measure |
HalfLytely With 5mg Bisacodyl
n=154 participants at risk
Investigational dose
|
HalfLytely With 10mg Bisacodyl
n=154 participants at risk
Active Control
|
|---|---|---|
|
General disorders
Overall Discomfort
|
56.5%
87/154
|
66.2%
102/154
|
|
Gastrointestinal disorders
Abdominal fullness
|
39.6%
61/154
|
52.6%
81/154
|
|
Gastrointestinal disorders
Abdominal cramping
|
37.7%
58/154
|
46.1%
71/154
|
|
Gastrointestinal disorders
Nausea
|
34.4%
53/154
|
42.2%
65/154
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
15/154
|
6.5%
10/154
|
Additional Information
John McGowan, Associate Director, Clinical Research
Braintree Laboratories, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 360 days from the time submitted to the sponsor for review. The sponsor cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER