Measurement of Gastric Emptying During and After COLOKIT® Intake

Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Sodium phosphate

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COLOKIT®	Drug: Sodium phosphate; 32 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with a residual antral volume lower than 20 mL	after 2nd treatment regimen intake

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	After drug intake
Acceptability of COLOKIT®.	After drug intake
Colonoscopy results	After colonoscopy.

Collaborators and Investigators

• Sponsor: Laboratoires Mayoly Spindler
• Investigators: Principal Investigator: Stanislas CHAUSSADE, Professor, Cochin Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): November 29, 2012
• Last Update Submitted That Met QC Criteria: November 28, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: FCOL 111; 2011-002953-80 (EudraCT Number)