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

This study has been completed.
Sponsor:
Collaborator:
International Clinical Trials Association
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00605228
First received: January 17, 2008
Last updated: January 29, 2008
Last verified: January 2008
  Purpose

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®.

Condition Intervention Phase
Gastrointestinal Diseases
Drug: MOVIPREP
Drug: COLOPEG
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Multicentre, Single-Blind, Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation.

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • 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] [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: May 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MOVIPREP
2L Drug
Active Comparator: 2 Drug: COLOPEG
4L Drug

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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605228

Locations
France
Centre Hospitalier Du Mans
Le Mans, Lemans, France, 72000
Cabinet de gatsro-entérologie
Anglet, France, 64600
Cabinet de gastroentérologie
Aubagne, France, 13400
Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON
Avignon, France, 84029
Clinique de La Châtaigneraie
Beaumont, France, 63110
Cabinet de gastro-entérologie
Bordeaux, France, 33300
Clinique Saint Martin
Caen, France, 14000
Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL
Creteil, France, 94000
Centre Des Maladies Du Foie Et de L'Appareil Digestif
Irigny, France, 69540
Cabinet de gastroentérologie
Les Sables D'olonne, France, 85100
Cabinet Medical Jemmapes
Lille, France, 59800
Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS
Nancy, France, 54511
Service de Gastroentérologie, HOPITAL DE L'ARCHET
Nice, France, 06200
Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE
Paris, France, 75475
Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU
Paris, France, 75015
Hopital F. Mitterand
PAU, France, 64000
Polyclinique Courlancy
Reims, France, 51100
Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire
Rennes, France, 35000
Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE
Rouen, France, 76031
Clinique Saint Jean Languedoc
Toulouse, France, 31400
Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours
Tours, France, 37000
Sponsors and Collaborators
Norgine
International Clinical Trials Association
Investigators
Principal Investigator: Thierry PONCHON, MD HOPITAL EDOUARD HERRIOT
  More Information

Publications:
Responsible Party: Cécile DUGUE Medical Director, Norgine Pharma
ClinicalTrials.gov Identifier: NCT00605228     History of Changes
Other Study ID Numbers: NRL994-02/2006 (FFS)
Study First Received: January 17, 2008
Last Updated: January 29, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 27, 2014