A Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation (NORMO)
This study has been completed.
Sponsor:
Norgine
Collaborator:
ICTA PM
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00605228
First received: January 17, 2008
Last updated: January 29, 2008
Last verified: January 2008
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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:
- The patient's written informed consent must be obtained prior to inclusion.
- 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.
Exclusion Criteria:
- 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.
-
Contacts and Locations
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
ICTA PM
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 May 19, 2013