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OpenTrials
Completed

NCT Number: NCT01398098

Measurement of Gastric Emptying During and After COLOKIT® Intake

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

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cochin Hospital

Paris, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Women pregnant or likely to be (without contraception) or nursing.
  • 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.

Treatment and study plan

sodium phosphate

Drug

32 tablets

Primary outcomes

  1. Percentage of patients with a residual antral volume lower than 20 mL

    Time frame: after 2nd treatment regimen intake

Secondary outcomes

  1. Adverse events

    Time frame: After drug intake

  2. Acceptability of COLOKIT®.

    Time frame: After drug intake

  3. Colonoscopy results

    Time frame: After colonoscopy.

Sponsors and collaborators

Lead sponsor

Laboratoires Mayoly Spindler

Industry

Registry information

Official study title

Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2011
Registry last updated
Nov 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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