Clinical trial NCT00605228: A Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation
Official title: A Randomised, Multicentre, Single-Blind, Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Diseases
Lead sponsor: Norgine
Sponsor class: INDUSTRY
Collaborators: name: International Clinical Trials Association
First posted: 2008-01-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.

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 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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Primary outcomes:
measure: 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]
timeFrame: 1 day
Secondary outcomes:
measure: 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.
timeFrame: 1 day
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
state: Lemans
city: Anglet
country: France
facility: Cabinet de gatsro-entérologie
city: Aubagne
country: France
facility: Cabinet de gastroentérologie
city: Avignon
country: France
facility: Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON
city: Beaumont
country: France
facility: Clinique de La Châtaigneraie
city: Bordeaux
country: France
facility: Cabinet de gastro-entérologie
city: Caen
country: France
facility: Clinique Saint Martin
city: Creteil
country: France
facility: Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL
city: Irigny
country: France
facility: Centre Des Maladies Du Foie Et de L'Appareil Digestif
city: Les Sables D'olonne
country: France
facility: Cabinet de gastroentérologie
city: Lille
country: France
facility: Cabinet Medical Jemmapes
city: Nancy
country: France
facility: Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS
city: Nice
country: France
facility: Service de Gastroentérologie, HOPITAL DE L'ARCHET
city: Paris
country: France
facility: Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU
city: Paris
country: France
facility: Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE
city: PAU
country: France
facility: Hopital F. Mitterand
city: Reims
country: France
facility: Polyclinique Courlancy
city: Rennes
country: France
facility: Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire
city: Rouen
country: France
facility: Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE
city: Toulouse
country: France
facility: Clinique Saint Jean Languedoc
city: Tours
country: France
facility: Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours
Study officials:
affiliation: HOPITAL EDOUARD HERRIOT
name: Thierry PONCHON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.