Clinical Evaluation of a New Reduced Volume Bowel Preparation

Sponsor

Norgine (Industry)

Overall Status

Completed

CT.gov ID

NCT00321230

Collaborator

(none)

Enrollment

Location

3.9

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 2001

Study Completion Date :

May 1, 2001

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Lariboisière, Endoscopy Department	Paris		France	75010

Sponsors and Collaborators

Norgine

Investigators

Principal Investigator: Alain Bitoun, MD, Hôpital Lariboisière

Study Documents (Full-Text)

None provided.

More Information

Publications

Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00321230

Other Study ID Numbers:

NRL994-02/2000
02/2000

First Posted:

May 3, 2006

Last Update Posted:

Apr 16, 2008

Last Verified:

Apr 1, 2008

Keywords provided by , ,

Colon cleansing

Additional relevant MeSH terms:

Ascorbic Acid

Polyethylene glycol 3350

Study Results

No Results Posted as of Apr 16, 2008