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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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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   (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 )
Study First Received: July 13, 2011
Last Updated: November 28, 2012

ClinicalTrials.gov processed this record on August 17, 2017