Clinical Trial Results:
Optimizing Colon Capsule Endoscopy in follow up program on patients with colorectal polyps assessing three booster procedures for motility enhancement
Summary
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EudraCT number |
2016-002237-30 |
Trial protocol |
DK |
Global end of trial date |
01 Nov 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Jan 2021
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First version publication date |
27 Jan 2021
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Other versions |
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Summary report(s) |
Article |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CAREforCOLONbooster
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
Baagøes Alle, Svendborg, Denmark,
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Public contact |
Research Unit,Department of Surgery, OUH Odense University Hospital, Svendborg Sygehus, akd@rsyd.dk
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Scientific contact |
Research Unit,Department of Surgery, OUH Odense University Hospital, Svendborg Sygehus, akd@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Jun 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Nov 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Nov 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The objective of the study is to establish which booster procedure best facilitates timely excretion of CCE.
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Protection of trial subjects |
Exclusion criteria were previous bowel surgery except appendectomy,
renal insufficiency, pacemaker, pregnancy,
breastfeeding, inflammatory bowel disease or allergies towards
active substances administered in the trial. All participants who
commenced bowel preparation were included in the analyses as
intention to treat. All participants
signed informed written consent.
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Background therapy |
All participants received a bowel preparation consisting of magnesium tablets, 2-L split-dose PEG solution (Moviprep, Norgine, Denmark) and were kept on a diet of watery fluids. | ||
Evidence for comparator |
We designed a three arm randomized trial to assess three different booster regimen´s effect on excretion. Moviprep, Eziclen and moviprep with gastrografin has previously been reported as well tolerated, low risk and effective. | ||
Actual start date of recruitment |
01 Feb 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 180
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Worldwide total number of subjects |
180
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EEA total number of subjects |
180
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
109
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From 65 to 84 years |
71
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients scheduled for follow-up colonoscopy at Odense University Hospital and Hospital of Southwest Jutland between February 1st, 2017 and November 1st, 2017 were screened. Inclusion criteria were follow-up due to previous neoplastic findings or familial history of colorectal cancer and age 18 to 70 years.Exclusion criteria were previous bowe | ||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 1707 patients were screened for eligibility and 517 invitations were sent. We included 180 eligible consecutive patients that responded and fulfilled the criteria. We included 140 (78%) participants at center one, and 40 (22%) participants at center two | ||||||||||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||||
Roles blinded |
Data analyst [1] | ||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Moviprep | ||||||||||||||||||||
Arm description |
Moviprep booster | ||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||
Investigational medicinal product name |
Moviprep
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution in sachet
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Routes of administration |
Oral use
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Dosage and administration details |
Booster regimen
Signal 1
(Capsule reached the small bowel)
0.75 L Moviprep® solution
0.75 L water
Signal 2
(3 hours after signal 1)
0.25 L Moviprep® solution
0.25 L water
Signal 3
(2 hours after signal 2)
10 mg Rectal Bisacodyl
1 hour after Signal 3: No dietary restrictions
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Arm title
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Eziclen | ||||||||||||||||||||
Arm description |
Eziclen Booster | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Eziclen
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Booster regimen
Signal 1
(Capsule reached the small bowel)
0.25 L Eziclen® solution
0.75 L water
Signal 2
(3 hours after signal 1)
0.25 L Eziclen® solution
0.75 L water
Signal 3
(2 hours after signal 2) Group A Group B Group C
10 mg Rectal Bisacodyl
1 hour after Signal 3: No dietary restrictions
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Arm title
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Moviprep + Gastrografin | ||||||||||||||||||||
Arm description |
Moviprep + Gastrografin booster | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Moviprep
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution in sachet
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Routes of administration |
Oral use
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Dosage and administration details |
Booster regimen
Signal 1
(Capsule reached the small bowel)
0.75 L Moviprep® solution
0.75 L water
Signal 2
(3 hours after signal 1)
0.25 L Moviprep® solution
0.25 L water
Signal 3
(2 hours after signal 2)
10 mg Rectal Bisacodyl
1 hour after Signal 3: No dietary restrictions
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Investigational medicinal product name |
Gastrografin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Booster regimen
Signal 1
(Capsule reached the small bowel)
50 mL Gastrografin®
Signal 2
(3 hours after signal 1)
25 mL Gastrografin®
Signal 3
(2 hours after signal 2)
10 mg Rectal Bisacodyl
1 hour after Signal 3: No dietary restrictions
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Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: Included individuals and nurses delivering the investigations were not blinded. But arm randomization was blinded to assessors, investigator and data analyst. |
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Baseline characteristics reporting groups
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Reporting group title |
Moviprep
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Reporting group description |
Moviprep booster | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Eziclen
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Reporting group description |
Eziclen Booster | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Moviprep + Gastrografin
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Reporting group description |
Moviprep + Gastrografin booster | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Moviprep
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Reporting group description |
Moviprep booster | ||
Reporting group title |
Eziclen
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Reporting group description |
Eziclen Booster | ||
Reporting group title |
Moviprep + Gastrografin
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Reporting group description |
Moviprep + Gastrografin booster |
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End point title |
Capsule exretion | ||||||||||||||||||||
End point description |
Timely anal excretion of the capsule while recording
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End point type |
Primary
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End point timeframe |
At investigation
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Statistical analysis title |
confidence interval | ||||||||||||||||||||
Comparison groups |
Moviprep v Eziclen v Moviprep + Gastrografin
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Number of subjects included in analysis |
180
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||||||||||
P-value |
> 0.05 | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Confidence interval |
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Notes [1] - 95% Confidence intervals was reported for each group |
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End point title |
Adequate bowel preparation | ||||||||||||||||||||
End point description |
Bowel cleanliness was graded according to the validated Leighton-Rex scale from 1-4 (1: Poor, 2: Fair, 3: Good, 4: Excellent)[30]. Bowel cleansing grade 2-4 was regarded as adequate for clinical purposes. An investigation with no images of the colon due to slow transit was regarded as bowel cleansing grade 1. A video with images of the anal verge was regarded as excreted.
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End point type |
Secondary
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End point timeframe |
At video investigation
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No statistical analyses for this end point |
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End point title |
Complete examination | ||||||||||||||||||||
End point description |
In order to obtain a complete examination the individual should have a timely capsule excretion and an adequate bowel preparation
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End point type |
Secondary
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End point timeframe |
Composite endpoint
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Trial start and untill 2 days after capsule excretion.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
SNOMED CT | ||||||||||||||||||||||||||||
Dictionary version |
2
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Reporting groups
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Reporting group title |
Moviprep
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Reporting group description |
Moviprep booster | ||||||||||||||||||||||||||||
Reporting group title |
Eziclen
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Reporting group description |
Eziclen Booster | ||||||||||||||||||||||||||||
Reporting group title |
Moviprep + Gastrografin
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Reporting group description |
Moviprep + Gastrografin booster | ||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |