Trial Outcomes & Findings for Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients (NCT NCT01576120)
NCT ID: NCT01576120
Last Updated: 2019-08-08
Results Overview
effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment The duration of the procedure in this study is 1 day of colon preparation and 1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
The end points and outcomes measures will be evaluated within 4 months from end of enrollment
Results posted on
2019-08-08
Participant Flow
Participant milestones
| Measure |
Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.
4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)
|
Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.
4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients
Baseline characteristics by cohort
| Measure |
Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.
n=21 Participants
4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)
|
Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.
n=19 Participants
4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The end points and outcomes measures will be evaluated within 4 months from end of enrollmenteffectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment The duration of the procedure in this study is 1 day of colon preparation and 1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted.
Outcome measures
| Measure |
Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.
n=21 Participants
4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)
|
Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.
n=19 Participants
4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)
|
|---|---|---|
|
• Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients
|
62 percentage of participants
Interval 38.0 to 62.0
|
79 percentage of participants
Interval 54.0 to 94.0
|
Adverse Events
Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.
n=21 participants at risk
4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)
|
Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.
n=19 participants at risk
4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI
bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)
|
|---|---|---|
|
Gastrointestinal disorders
Adverse event related to the preparation
|
28.6%
6/21
|
10.5%
2/19
|
|
Gastrointestinal disorders
Adverse event not related to study procedure
|
14.3%
3/21
|
10.5%
2/19
|
Additional Information
Ravit Peled | Clinical Trials Manager
Given Imaging
Phone: +972 (4) 909-7894
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place