Status:
COMPLETED
MOVIPREP® Versus PICOLAX® Pilot Study
Lead Sponsor:
Norgine
Conditions:
Colonoscopy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This will be a randomised, single-centre, single-blind, parallel-group, pilot study in patients undergoing colonoscopy. The primary objective is to evaluate the efficacy of MOVIPREP® versus PICOLAX® ...
Detailed Description
Gut cleansing will be performed using a split dose of MOVIPREP®, 1-litre solution (1x sachet A and 1x sachet B) in the evening prior to the day of colonoscopy and 1-litre solution (1x sachet A and 1x ...
Eligibility Criteria
Inclusion
- written informed consent obtained prior to inclusion
- male or female, aged 18 to 80 years, inclusive, scheduled to undergo a complete colonoscopy
- willing, able and competent to complete the entire procedure and to comply with study instructions
- females of childbearing potential must employ an adequate method of contraception
- if an adequate method of contraception is not being used, the patient will be post hysterectomy, post bilateral oophorectomy, post menopause or have any other condition which precludes pregnancy
- females of childbearing potential must undergo a pregnancy test
Exclusion
- ileus
- gastro-intestinal obstruction or perforation
- toxic megacolon, toxic colitis
- congestive heart failure (New York Heart Association \[NYHA\] III + IV)
- acute life-threatening cardiovascular disease
- acute surgical abdominal conditions
- untreated or uncontrolled arterial hypertension
- known clinically significant reduced renal function with creatinine \> 170 µmol/L
- known clinically significant reduced liver function
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00312481
Start Date
July 1 2005
End Date
May 1 2006
Last Update
December 17 2007
Active Locations (1)
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1
John Radcliffe Hospital, Department of Gastroenterology, Endoscopy Unit, Headley Way, Headington
Oxford, Oxfordshire, United Kingdom, OX3 9DU