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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006873-25-FR

Enrollment

400

Registered

2007-02-15

Start date

2007-03-14

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel cleansing prior to colonoscopy or radiology

Interventions

Trade Name: MOVIPREP Product Name: MOVIPREP Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Macrogol 3350, Sodium sulfate anhydrous, Sodium chloride, Potassium chloride Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Age 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,

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026