Measurement of Gastric Emptying During and After COLOKIT® Intake

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Ultra-sound study to assess changes in intragastric volume after bowel preparation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires Mayoly Spindler

Criteria

Inclusion Criteria:

• 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 Criteria:

1. Women pregnant or likely to be (without contraception) or nursing.

2. 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.