Measurement of Gastric Emptying During and After COLOKIT® Intake

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier:
NCT01398098
First received: July 13, 2011
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Colonoscopy
Drug: Sodium phosphate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®

Resource links provided by NLM:


Further study details as provided by Laboratoires Mayoly Spindler:

Primary Outcome Measures:
  • Percentage of patients with a residual antral volume lower than 20 mL [ Time Frame: after 2nd treatment regimen intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: After drug intake ] [ Designated as safety issue: Yes ]
  • Acceptability of COLOKIT®. [ Time Frame: After drug intake ] [ Designated as safety issue: No ]
  • Colonoscopy results [ Time Frame: After colonoscopy. ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COLOKIT® Drug: Sodium phosphate
32 tablets

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01398098

Locations
France
Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Laboratoires Mayoly Spindler
Investigators
Principal Investigator: Stanislas CHAUSSADE, Professor Cochin Hospital
  More Information

No publications provided

Responsible Party: Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier: NCT01398098     History of Changes
Other Study ID Numbers: FCOL 111, 2011-002953-80
Study First Received: July 13, 2011
Last Updated: November 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on August 21, 2014