Status:
COMPLETED
Clinical Evaluation of a New Reduced Volume Bowel Preparation
Lead Sponsor:
Norgine
Conditions:
Colonoscopy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.
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 admit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
May 1 2001
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00321230
Start Date
January 1 2001
End Date
May 1 2001
Last Update
April 16 2008
Active Locations (1)
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1
Hôpital Lariboisière, Endoscopy Department
Paris, France, 75010