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

NCT00605228 | Completed Phase 4

• 1 other identifier: NRL994-02/2006 (FFS)
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 21

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®.

Conditions

Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: MOVIPREP

2

ACTIVE COMPARATOR

Drug: COLOPEG

Interventions

MOVIPREP DRUG

2L Drug

1

COLOPEG DRUG

4L Drug

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, outpatients between 18 and 85 years old with an indication to colonoscopy.
• Willing and able to complete the entire procedure and to comply with study instructions.
• Females of childbearing potential must employ an adequate method of birth control.

You may not qualify if:

• Age \< 18 or \> 85 years old,
• Ileus,
• Suspected intestinal occlusion or perforation,
• Toxic megacolon with severe inflammation conditions of intestinal tract (patients with Crohn's Disease or Ulcerative Colitis included),
• Gastroparesis,
• Congestive heart failure NYHA III or IV,
• Documented Carcinoma or any other colic disease leading to a fragile mucosa,
• Documented severe renal insufficiency history
• Known hypersensitivity to MoviPrep®, Colopeg® or to any of their components (PEG, ascorbic acid etc.),
• Known deficiency in G6PD and/or phenylketonuria,
• Concurrent participation in an investigational drug/device study or participation within 30 days of study entry,
• Females who are pregnant, or planning a pregnancy. Females of child bearing potential not using reliable methods of birth control,
• 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.
• 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.

Sponsors & Collaborators

• Norgine: lead
• International Clinical Trials Association: collaborator

Study Sites (21)

Centre Hospitalier Du Mans

Le Mans, Lemans, 72000, France

Location

Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS

Nancy, Nancy, 54511, France

Location

Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE

Rouen, Rouen, 76031, France

Location

Cabinet de gatsro-entérologie

Anglet, 64600, France

Location

Cabinet de gastroentérologie

Aubagne, 13400, France

Location

Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON

Avignon, 84029, France

Location

Clinique de La Châtaigneraie

Beaumont, 63110, France

Location

Cabinet de gastro-entérologie

Bordeaux, 33300, France

Location

Clinique Saint Martin

Caen, 14000, France

Location

Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL

Créteil, 94000, France

Location

Centre Des Maladies Du Foie Et de L'Appareil Digestif

Irigny, 69540, France

Location

Cabinet de gastroentérologie

Les Sables-d'Olonne, 85100, France

Location

Cabinet Medical Jemmapes

Lille, 59800, France

Location

Service de Gastroentérologie, HOPITAL DE L'ARCHET

Nice, 06200, France

Location

Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU

Paris, 75015, France

Location

Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE

Paris, 75475, France

Location

Hopital F. Mitterand

Pau, 64000, France

Location

Polyclinique Courlancy

Reims, 51100, France

Location

Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire

Rennes, 35000, France

Location

Clinique Saint Jean Languedoc

Toulouse, 31400, France

Location

Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours

Tours, 37000, France

Location

Related Publications (1)

• Bitoun A, Ponchon T, Barthet M, Coffin B, Dugue 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. doi: 10.1111/j.1365-2036.2006.03167.x. Epub 2006 Nov 10.

  PMID: 17094774 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

MoviPrep

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Thierry PONCHON, MD

  HOPITAL EDOUARD HERRIOT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 30, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 30, 2008

Record last verified: 2008-01

Locations

FR (21)