A randomised, multicentre, single-blind, phase IV study, of the efficacy, safety and acceptability of MoviPrep® versus Colopeg® in colonoscopy preparation.

Phase 1

• 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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-15
• Study Completion: 2007-12-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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
Main Objective: <br>-To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.<br><br>;Secondary Objective: -To assess the safety of Moviprep® versus Colopeg®.<br>-To assess acceptability of Moviprep® versus Colopeg®.<br>;Primary end point(s): -The proportion of patients with successful colon cleansing as judged by blinded reviewers assessing videotapes recorded during the colonoscopy.