Measurement of Gastric Emptying During and After COLOKIT® Intake
This study has been completed.
Sponsor:
Laboratoires Mayoly Spindler
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
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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:
- 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.
Contacts and Locations 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) |
Additional relevant MeSH terms:
|
Sodium phosphate Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013