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

Gastrointestinal Diseases Clinical Trial

— NORMO  

Official title:

A Randomised, Multicentre, Single-Blind, Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605228
• Other study ID #: NRL994-02/2006 (FFS)
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2008
• Last updated: January 29, 2008
• Start date: May 2007
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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®.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Drug:
• MOVIPREP
2L Drug
• COLOPEG
4L Drug

Locations

Country	Name	City	State
France	Cabinet de gatsro-entérologie	Anglet
France	Cabinet de gastroentérologie	Aubagne
France	Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON	Avignon
France	Clinique de La Châtaigneraie	Beaumont
France	Cabinet de gastro-entérologie	Bordeaux
France	Clinique Saint Martin	Caen
France	Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL	Creteil
France	Centre Des Maladies Du Foie Et de L'Appareil Digestif	Irigny
France	Centre Hospitalier Du Mans	Le Mans	Lemans
France	Cabinet de gastroentérologie	Les Sables D'olonne
France	Cabinet Medical Jemmapes	Lille
France	Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS	Nancy
France	Service de Gastroentérologie, HOPITAL DE L'ARCHET	Nice
France	Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU	Paris
France	Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE	Paris
France	Hopital F. Mitterand	PAU
France	Polyclinique Courlancy	Reims
France	Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire	Rennes
France	Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE	Rouen
France	Clinique Saint Jean Languedoc	Toulouse
France	Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Norgine	International Clinical Trials Association

Country where clinical trial is conducted

France, 

References & Publications (1)

Bitoun A, Ponchon T, Barthet M, Coffin B, Dugué C, Halphen M; Norcol Group. Results of a prospective randomised multicentre controlled trial comparing a new 2-L ascorbic acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution in patients undergoing elective colonoscopy. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1631-42. Epub 2006 Nov 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No