Status:
COMPLETED
MOVIPREP® Versus NaP Pivotal Phase III Study
Lead Sponsor:
Norgine
Conditions:
Colonoscopy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be ...
Detailed Description
Multicentric (15 centres), prospective, randomised, single-blinded phase III pivotal study in patients undergoing a colonoscopy. Gut cleansing will be performed using 2 litres of NRL994 gut lavage sol...
Eligibility Criteria
Inclusion
- male or female, out and inpatients to be at least 18 years old and \<75 years old sent to the endoscopic ward for diagnostic or therapeutic colonoscopy
- willing and able to complete the entire procedure and to comply with study instructions
- females of childbearing potential must employ an adequate method of contraception.
Exclusion
- age \<18 or \> 75 years old
- ileus
- suspected intestinal occlusion or perforation
- toxic or congenital megacolon
- history of colonic resection
- patients with Crohn's disease or ulcerative colitis
- congestive heart failure NYHA III or IV
- documented renal insufficiency history with creatinine \>170µmol/l
- known hypersensitivity to polyethylene glycols or Na phosphate and/or vitamin C
- concurrent participation in an investigational drug study or participation within 90 days of study entry
- females who are pregnant, or planning a pregnancy. Females of childbearing potential not using reliable methods of contraception
- 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 :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00322062
Start Date
April 1 2002
End Date
March 1 2003
Last Update
April 16 2008
Active Locations (18)
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1
Hôpital Jean Minjoz
Besançon, France, 25030
2
Hôpital Mourier
Colombes, France, 92700
3
Hôpital Huriez
Lille, France, 59037
4
Hôpital Dupuytren
Limoges, France, 87000