Measurement of Gastric Emptying During and After COLOKIT® Intake

Mayoly Spindler

Status and phase: Completed; Phase 2

Conditions: Colonoscopy

Treatments: Drug: Sodium phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01398098

FCOL 111

2011-002953-80 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

COLOKIT®

Experimental group

Treatment:

Drug: Sodium phosphate