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

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

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®.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Drug: MOVIPREP; Drug: 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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Anglet, France, 64600
    • Cabinet de gatsro-entérologie
  • Aubagne, France, 13400
    • Cabinet de gastroentérologie
  • Avignon, France, 84029
    • Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON
  • Beaumont, France, 63110
    • Clinique De La Chataigneraie
  • Bordeaux, France, 33300
    • Cabinet de Gastro-Enterologie
  • Caen, France, 14000
    • Clinique Saint Martin
  • Creteil, France, 94000
    • Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL
  • Irigny, France, 69540
    • Centre des maladies du foie et de l'appareil digestif
  • Les Sables D'olonne, France, 85100
    • Cabinet de gastroentérologie
  • Lille, France, 59800
    • Cabinet Medical Jemmapes
  • Nancy, France, 54511
    • Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS
  • Nice, France, 06200
    • Service de Gastroentérologie, HOPITAL DE L'ARCHET
  • PAU, France, 64000
    • Hopital F. Mitterand
  • Paris, France, 75015
    • Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU
  • Paris, France, 75475
    • Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE
  • Reims, France, 51100
    • Polyclinique Courlancy
  • Rennes, France, 35000
    • Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire
  • Rouen, France, 76031
    • Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE
  • Toulouse, France, 31400
    • Clinique Saint Jean Languedoc
  • Tours, France, 37000
    • Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours
  • Lemans
    • Le Mans, Lemans, France, 72000
      • Centre Hospitalier Du Mans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: MOVIPREP; 2L Drug
Active Comparator: 2	Drug: COLOPEG; 4L Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Norgine
• Collaborators: International Clinical Trials Association
• Investigators: Principal Investigator: Thierry PONCHON, MD, Hôpital Edouard Herriot

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: January 17, 2008
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Estimate): January 30, 2008
• Last Update Submitted That Met QC Criteria: January 29, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: NRL994-02/2006 (FFS)