Measurement of Gastric Emptying During and After COLOKIT® Intake

Colonoscopy Clinical Trial

Official title:

Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398098
• Other study ID #: FCOL 111
• Secondary ID: 2011-002953-80
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2011
• Last updated: November 28, 2012
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Laboratoires Mayoly Spindler
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Sodium phosphate
32 tablets

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Mayoly Spindler

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a residual antral volume lower than 20 mL		after 2nd treatment regimen intake	No
Secondary	Adverse events		After drug intake	Yes
Secondary	Acceptability of COLOKIT®.		After drug intake	No
Secondary	Colonoscopy results		After colonoscopy.	No