Measurement of Gastric Emptying During and After COLOKIT® Intake
Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®
2 other identifiers
interventional
30
1 country
1
Brief Summary
Ultra-sound study to assess changes in intragastric volume after bowel preparation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 29, 2012
November 1, 2012
7 months
July 13, 2011
November 28, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with a residual antral volume lower than 20 mL
after 2nd treatment regimen intake
Secondary Outcomes (3)
Adverse events
After drug intake
Acceptability of COLOKIT®.
After drug intake
Colonoscopy results
After colonoscopy.
Study Arms (1)
COLOKIT®
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subject who signed an informed consent to participate in the trial.
- Subject affiliated with Social Security
- Men and women aged 18 to 75 years.
- Subject with an indication of scheduled outpatient colonoscopy.
- colonoscopy performed within six hours after the second sequence COLOKIT®.
- Subject able to swallow tablets.
You may not qualify if:
- Women pregnant or likely to be (without contraception) or nursing.
- Subject having any of the following diseases or conditions:
- allergy or hypersensitivity to the product tested or any of its excipients,
- nausea, vomiting or abdominal pain,
- clinically significant renal failure,
- primary hyperparathyroidism associated with hypercalcemia,
- congestive heart failure,
- ascites,
- a known or suspected bowel obstruction,
- megacolon (congenital or acquired)
- intestinal perforation,
- ileus,
- an inflammatory disease or suspected inflammatory bowel disease,
- swallowing disorders,
- known digestive motor disorders (gastroparesis, scleroderma, mega-esophagus),
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cochin Hospital
Paris, 75014, France
Related Publications (1)
Coriat R, Polin V, Oudjit A, Henri F, Dhooge M, Leblanc S, Delchambre C, Esch A, Tabouret T, Barret M, Prat F, Chaussade S. Gastric emptying evaluation by ultrasound prior colonoscopy: an easy tool following bowel preparation. World J Gastroenterol. 2014 Oct 7;20(37):13591-8. doi: 10.3748/wjg.v20.i37.13591.
PMID: 25309090DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Stanislas CHAUSSADE, Professor
Cochin Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2011
First Posted
July 20, 2011
Study Start
October 1, 2011
Primary Completion
May 1, 2012
Study Completion
September 1, 2012
Last Updated
November 29, 2012
Record last verified: 2012-11