Clinical Evaluation of a New Reduced Volume Bowel Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00321230
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : April 16, 2008
Information provided by:

Brief Summary:
Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2001
Study Completion Date : May 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Primary Outcome Measures :
  1. 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 :
  1. 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).
  2. Amount of fluid removed from the colon during the colonoscopy.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00321230

Hôpital Lariboisière, Endoscopy Department
Paris, France, 75010
Sponsors and Collaborators
Principal Investigator: Alain Bitoun, MD Hôpital Lariboisière

Responsible Party: Dr Marc Halphen, Norgine Identifier: NCT00321230     History of Changes
Other Study ID Numbers: NRL994-02/2000
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008

Keywords provided by Norgine:
Colon cleansing

Additional relevant MeSH terms:
Ascorbic Acid
Polyethylene glycol 3350
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances
Gastrointestinal Agents