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

Phase 4

Completed

• Conditions: Gastrointestinal Diseases
• Interventions: Drug: COLOPEG; Drug: MOVIPREP

• Registration Number: NCT00605228
• Lead Sponsor: Norgine

Brief Summary

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®.

Detailed 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).

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-01
• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-29
• Last Update Submitted: 2008-01-29
• Study First Posted: 2008-01-30
• Last Update Posted: 2008-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	COLOPEG	-
1	MOVIPREP	-

Primary Outcome Measures

Name	Time	Method
the proportion of patients with successful colon cleansing as judged by blinded reviewers on the basis of videotapes recorded during the colonoscopy [the blinded reviewers will grade the colon cleansing only once]	1 day

Secondary Outcome Measures

Name	Time	Method
the proportion of patients with successful colon cleansing as judged by the colonoscopist, the colonic segment cleansing score as assessed by the colonoscopist and the blinded reviewers and Aronchick global score as assessed by blinded reviewers.	1 day

Trial Locations

Locations (20)

Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON; 🇫🇷 Avignon, France

Clinique de La Châtaigneraie; 🇫🇷 Beaumont, France

Centre Des Maladies Du Foie Et de L'Appareil Digestif; 🇫🇷 Irigny, France

Centre Hospitalier Du Mans; 🇫🇷 Le Mans, Lemans, France

Clinique Saint Martin; 🇫🇷 Caen, France

Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU; 🇫🇷 Paris, France

Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE; 🇫🇷 Paris, France

Cabinet de gastro-entérologie; 🇫🇷 Bordeaux, France

Polyclinique Courlancy; 🇫🇷 Reims, France

Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire; 🇫🇷 Rennes, France

Cabinet de gatsro-entérologie; 🇫🇷 Anglet, France

Hopital F. Mitterand; 🇫🇷 PAU, France

Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours; 🇫🇷 Tours, France

Clinique Saint Jean Languedoc; 🇫🇷 Toulouse, France

Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE; 🇫🇷 Rouen, France

Cabinet de gastroentérologie; 🇫🇷 Les Sables D'olonne, France

Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL; 🇫🇷 Creteil, France

Cabinet Medical Jemmapes; 🇫🇷 Lille, France

Service de Gastroentérologie, HOPITAL DE L'ARCHET; 🇫🇷 Nice, France

Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS; 🇫🇷 Nancy, France