Trial Outcomes & Findings for Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure (NCT NCT02481219)
NCT ID: NCT02481219
Last Updated: 2017-03-07
Results Overview
The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
Within two weeks of study procedure
Results posted on
2017-03-07
Participant Flow
Participant milestones
| Measure |
Bowel Preparation Regimen -Control
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
62
|
|
Overall Study
COMPLETED
|
58
|
61
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure
Baseline characteristics by cohort
| Measure |
Bowel Preparation Regimen -Control
n=60 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
n=62 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
Total
n=122 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
|
58 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
53 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
62 participants
n=7 Participants
|
122 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within two weeks of study procedurePopulation: this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.
The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).
Outcome measures
| Measure |
Bowel Preparation Regimen -Control
n=44 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
n=54 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
|---|---|---|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Overall Good cleansing
|
70.5 percentage of particpants
|
59.3 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Cecum Good cleansing
|
54.0 percentage of particpants
|
52.7 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Cecum Fair cleansing
|
30.0 percentage of particpants
|
30.9 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Overall Excellent cleansing
|
6.8 percentage of particpants
|
16.7 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Cecum Excellent cleansing
|
14.0 percentage of particpants
|
14.6 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Ascending Excellent cleansing
|
12.2 percentage of particpants
|
18.2 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Transverse Excellent cleansing
|
10.6 percentage of particpants
|
14.6 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Descending Excellent cleansing
|
9.5 percentage of particpants
|
18.5 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Rectum Excellent cleansing
|
0 percentage of particpants
|
10.0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Ascending Good cleansing
|
63.3 percentage of particpants
|
60.0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Transverse Good cleansing
|
61.7 percentage of particpants
|
60.0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Descending Good cleansing
|
73.8 percentage of particpants
|
63.0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Rectum Good cleansing
|
56.1 percentage of particpants
|
52.0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Overall Fair cleansing
|
22.7 percentage of particpants
|
24.1 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Ascending Fair cleansing
|
22.5 percentage of particpants
|
21.8 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Transverse Fair cleansing
|
27.7 percentage of particpants
|
25.5 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Descending Fair cleansing
|
16.7 percentage of particpants
|
18.5 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Rectum Fair cleansing
|
46.5 percentage of particpants
|
36.0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Overall Poor cleansing
|
0 percentage of particpants
|
0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Cecum Poor cleansing
|
2.0 percentage of particpants
|
1.8 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Ascending Poor cleansing
|
2.0 percentage of particpants
|
0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Transverse Poor cleansing
|
0 percentage of particpants
|
0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Descending Poor cleansing
|
0 percentage of particpants
|
0 percentage of particpants
|
|
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
Rectum Poor cleansing
|
2.4 percentage of particpants
|
2.0 percentage of particpants
|
SECONDARY outcome
Timeframe: an expected average of 3 weeks from study procedurePopulation: This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.
Will be assessed from RAPID video in total and by segment
Outcome measures
| Measure |
Bowel Preparation Regimen -Control
n=47 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
n=55 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
|---|---|---|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Overall (any size)
|
46.8 percentage of participants
|
58.2 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Cecum (any size)
|
6.0 percentage of participants
|
14.6 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Transverse (polyps ≥10mm)
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Descending (polyps ≥10mm)
|
4.3 percentage of participants
|
3.6 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Ascending (any size)
|
14.0 percentage of participants
|
9.1 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Transverse (any size)
|
4.3 percentage of participants
|
7.3 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Descending (any size)
|
31.9 percentage of participants
|
29.1 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
rectum (any size)
|
24.4 percentage of participants
|
32.0 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Overall (polyps ≥6mm)
|
21.3 percentage of participants
|
36.4 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Cecum (polyps ≥6mm)
|
2.0 percentage of participants
|
12.7 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Ascending (polyps ≥6mm)
|
2.0 percentage of participants
|
3.6 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Transverse (polyps ≥6mm)
|
4.3 percentage of participants
|
7.3 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Descending (polyps ≥6mm)
|
12.8 percentage of participants
|
16.4 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Rectum (polyps ≥6mm)
|
7.3 percentage of participants
|
6.0 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Overall (polyps ≥10mm)
|
8.5 percentage of participants
|
14.6 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Cecum Overall (polyps ≥10mm)
|
0 percentage of participants
|
7.3 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Ascending Overall (polyps ≥10mm)
|
2.0 percentage of participants
|
3.6 percentage of participants
|
|
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Rectum (polyps ≥10mm)
|
4.9 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: an expected average of 3 weeks from study procedurePopulation: The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.
Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment
Outcome measures
| Measure |
Bowel Preparation Regimen -Control
n=46 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
n=55 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
|---|---|---|
|
Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE
|
2.8 hours
Interval 0.4 to 7.5
|
2.4 hours
Interval 0.0 to 5.5
|
SECONDARY outcome
Timeframe: an expected average of 3 weeks from study procedurePopulation: Per protocol analysis set
Will be assessed from RAPID video in total and by segment
Outcome measures
| Measure |
Bowel Preparation Regimen -Control
n=52 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
n=55 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
|---|---|---|
|
Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE
|
76.9 percentage of participants
|
90.9 percentage of participants
|
SECONDARY outcome
Timeframe: an expected average of 3 weeks from study procedurePopulation: PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake \<1h and \> 2.15h, Morning PEG intake \<1h and \>2:15 h, Capsule ingestion l\<45 min or \>75 min after PEG intake , Overall PEG intake volume is less than 3 liters
Will be assesses by applicable case report form (CRF)
Outcome measures
| Measure |
Bowel Preparation Regimen -Control
n=51 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
n=55 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
|---|---|---|
|
Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE
|
80.4 percentage of participants
|
90.9 percentage of participants
|
SECONDARY outcome
Timeframe: Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.Population: Full analysis set
Will be assesses by applicable CRF
Outcome measures
| Measure |
Bowel Preparation Regimen -Control
n=59 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
n=62 Participants
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
|---|---|---|
|
Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE
|
3.4 percentage of participants with >1 AE
|
19.4 percentage of participants with >1 AE
|
Adverse Events
Bowel Preparation Regimen -Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Bowel Preparation Regimen-Test
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bowel Preparation Regimen -Control
n=59 participants at risk
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Control
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
n=62 participants at risk
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
|---|---|---|
|
Eye disorders
Chronic Sinusitis
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
1.6%
1/62 • Number of events 1 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
Other adverse events
| Measure |
Bowel Preparation Regimen -Control
n=59 participants at risk
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Control
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl
|
Bowel Preparation Regimen-Test
n=62 participants at risk
Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
3.4%
2/59 • Number of events 3 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
1.6%
1/62 • Number of events 1 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
General disorders
Irritation
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
3.2%
2/62 • Number of events 2 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
1.6%
1/62 • Number of events 1 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
1.6%
1/62 • Number of events 1 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
Gastrointestinal disorders
Dyspesia
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
1.6%
1/62 • Number of events 1 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
1.6%
1/62 • Number of events 1 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
6.5%
4/62 • Number of events 4 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
1.6%
1/62 • Number of events 1 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
3.2%
2/62 • Number of events 3 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
Nervous system disorders
Haedache
|
1.7%
1/59 • Number of events 1 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
3.2%
2/62 • Number of events 2 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
|
Ear and labyrinth disorders
Eye swelling
|
0.00%
0/59 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
1.6%
1/62 • Number of events 1 • Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior written consent is required for PI to independently publish any study results before a multi-center publication is released. If a multi-center manuscript is not submitted for publication within 1 year after completion of the Trial, PI shall have the right to Publish results. Sponsor shall respond within 45 days and shall have the right to delay the Publication for an additional 90.
- Publication restrictions are in place
Restriction type: OTHER