Status:
COMPLETED
Measurement of Gastric Emptying During and After COLOKIT® Intake
Lead Sponsor:
Laboratoires Mayoly Spindler
Conditions:
Colonoscopy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Ultra-sound study to assess changes in intragastric volume after bowel preparation.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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),
- diabetes mellitus (insulin or non insulin-dependent)
- a history of gastric surgery (partial or total)
- a contraindication to the anesthesia required for the completion of the colonoscopy,
- Any clinical condition which, in the opinion of the investigator, would not allow the subject to perform the test in good conditions.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01398098
Start Date
October 1 2011
End Date
September 1 2012
Last Update
November 29 2012
Active Locations (1)
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1
Cochin Hospital
Paris, France, 75014