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Measurement of Gastric Emptying During and After COLOKIT® Intake

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ClinicalTrials.gov Identifier: NCT01398098
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : November 29, 2012
Sponsor:
Information provided by (Responsible Party):
Laboratoires Mayoly Spindler

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

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: Sodium phosphate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®
Study Start Date : October 2011
Primary Completion Date : May 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: COLOKIT® Drug: Sodium phosphate
32 tablets



Primary Outcome Measures :
  1. Percentage of patients with a residual antral volume lower than 20 mL [ Time Frame: after 2nd treatment regimen intake ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: After drug intake ]
  2. Acceptability of COLOKIT®. [ Time Frame: After drug intake ]
  3. Colonoscopy results [ Time Frame: After colonoscopy. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398098


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier: NCT01398098     History of Changes
Other Study ID Numbers: FCOL 111
2011-002953-80 ( EudraCT Number )
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: November 29, 2012
Last Verified: November 2012