Measurement of Gastric Emptying During and After COLOKIT® Intake

Phase 2

Completed

• Conditions: Colonoscopy
• Interventions: Drug: Sodium phosphate

• Registration Number: NCT01398098
• Lead Sponsor: Laboratoires Mayoly Spindler

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Study Start: 2011-10
• Primary Completion: 2012-05
• Study Completion: 2012-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-28
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COLOKIT®	Sodium phosphate	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a residual antral volume lower than 20 mL	after 2nd treatment regimen intake

Secondary Outcome Measures

Name	Time	Method
Adverse events	After drug intake
Acceptability of COLOKIT®.	After drug intake
Colonoscopy results	After colonoscopy.

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France