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Clinical Evaluation of a New Reduced Volume Bowel Preparation

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00321230
First received: May 2, 2006
Last updated: April 15, 2008
Last verified: April 2008
History of Changes
  Purpose

Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.


Condition Intervention Phase
Colonoscopy
 Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norgine:

Primary Outcome Measures:
  • Efficacy measured by a final scoring system i.e., "the overall quality of colonoscopy prep" that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas.

Secondary Outcome Measures:
  • Stool weight as recorded on the case report form for each stool as from start of gut cleansing (day -1) to the beginning of colonoscopy (day 0).
  • Amount of fluid removed from the colon during the colonoscopy.

Estimated Enrollment: 30
Study Start Date: January 2001
Estimated Study Completion Date: May 2001
Detailed Description:

Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new "Low Dose Bowel Prep" formulation for gut cleansing prior to colonoscopy.

Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the "Low Dose Bowel Prep" using a one-step intake mode.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female, inpatients 18 to 65 years old with indication for complete colonoscopy
  • the patient's written informed consent must be obtained prior to inclusion
  • willing and able to complete the entire procedure and to comply with study instructions

Exclusion Criteria:

  • ileus or toxic megacolon
  • intestinal obstruction or perforation
  • known of G6PD insufficiency
  • history of any colonic surgery
  • ischaemic cardiovascular disease
  • untreated or uncontrolled arterial hypertension (max >170mmHg, min >100mmHg)
  • renal insufficiency (creating above 45µmol/l)
  • abnormal laboratory values (clinically significant) for sodium, potassium,chloride, creatinine and hematocrit
  • cirrhosis of liver (Child-Pugh grade B or C)
  • females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
  • concurrent participation in an investigational drug study or participation within 30 days of study entry
  • subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results or may interfere significantly
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321230

Locations
France
Hôpital Lariboisière, Endoscopy Department
Paris, France, 75010
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Alain Bitoun, MD Hôpital Lariboisière
  More Information

Publications:

Responsible Party: Dr Marc Halphen, Norgine
ClinicalTrials.gov Identifier: NCT00321230     History of Changes
Other Study ID Numbers: NRL994-02/2000, 02/2000
Study First Received: May 2, 2006
Last Updated: April 15, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Norgine:
Colon cleansing

Additional relevant MeSH terms:
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
 Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013