A Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation (NORMO)

Norgine

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Diseases

Treatments: Drug: COLOPEG; Drug: MOVIPREP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00605228

NRL994-02/2006 (FFS)

Details and patient eligibility

About

Primary:

• To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.

Secondary:

• To assess the safety of Moviprep® versus Colopeg®.
• To assess acceptability of Moviprep® versus Colopeg®.

Full description

Primary efficacy analysis will be performed on the ITT population. Secondary efficacy analysis will be performed on both ITT and PP sets. Results will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old) and provided in individual data listings.

Safety analysis will be performed on the safety set (ITT population). Safety data of all patients exposed will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old).

Acceptability analysis will be performed on the ITT population. Acceptability data of all patients will be summarised by treatment and age (overall, 18-35, 36-49, 50-74 and 75-85 years old).

Enrollment: 400 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

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 phenylketonuria,

11. Concurrent participation in an investigational drug/device study or participation within 30 days of study entry,

12. Females who are pregnant, or planning a pregnancy. Females of child bearing potential not using reliable methods of birth control,

13. Clinically significant laboratory abnormality or disease which, in the opinion of the investigator, will create a risk for the patient, obscure the effects of study treatment or interfere with study results.

14. Vulnerable patients (protected by the law) and those admitted to a sanitary/social institution according to Art.L-1121-6 of the French Public Health Code.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: MOVIPREP

2

Active Comparator group

Treatment:

Drug: COLOPEG