A randomised, multicentre, single-blind, phase IV study, of the efficacy, safety and acceptability of MoviPrep® versus Colopeg® in colonoscopy preparation.
- Conditions
- Bowel cleansing prior to colonoscopy or radiology
- Registration Number
- EUCTR2006-006873-25-FR
- Lead Sponsor
- orgine Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 0
1.The patient's written informed consent must be obtained prior to inclusion.
2.Male or female, outpatients between 18 and 85 years old with an indication to colonoscopy.
3.Willing and able to complete the entire procedure and to comply with study instructions.
4.Females of childbearing potential must employ an adequate method of birth control.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Age < 18 or > 85 years old,
2.Ileus,
3.Suspected intestinal occlusion or perforation,
4.Toxic megacolon with severe inflammation conditions of intestinal tract (patients with Crohn's Disease or Ulcerative Colitis included),
5.Gastroparesis,
6.Congestive heart failure NYHA III or IV,
7.Documented Carcinoma or any other colic disease leading to a fragile mucosa,
8.Documented severe renal insufficiency history
9.Known hypersensitivity to MoviPrep®, Colopeg® or to any of their components (PEG, ascorbic acid etc.),
10.Known deficiency in G6PD and/or phenylcetonuria,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method