A Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation
NCT ID: NCT00605228
Last Updated: 2008-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2007-05-31
2007-12-31
Brief Summary
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\- 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
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
MOVIPREP
2L Drug
2
COLOPEG
4L Drug
Interventions
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MOVIPREP
2L Drug
COLOPEG
4L Drug
Eligibility Criteria
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Inclusion Criteria
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
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.
\-
18 Years
85 Years
ALL
No
Sponsors
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International Clinical Trials Association
OTHER
Norgine
INDUSTRY
Responsible Party
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Norgine Pharma
Principal Investigators
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Thierry PONCHON, MD
Role: PRINCIPAL_INVESTIGATOR
HOPITAL EDOUARD HERRIOT
Locations
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Centre Hospitalier Du Mans
Le Mans, Lemans, France
Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS
Nancy, Nancy, France
Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE
Rouen, Rouen, France
Cabinet de gatsro-entérologie
Anglet, , France
Cabinet de gastroentérologie
Aubagne, , France
Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON
Avignon, , France
Clinique de La Châtaigneraie
Beaumont, , France
Cabinet de gastro-entérologie
Bordeaux, , France
Clinique Saint Martin
Caen, , France
Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL
Créteil, , France
Centre Des Maladies Du Foie Et de L'Appareil Digestif
Irigny, , France
Cabinet de gastroentérologie
Les Sables-d'Olonne, , France
Cabinet Medical Jemmapes
Lille, , France
Service de Gastroentérologie, HOPITAL DE L'ARCHET
Nice, , France
Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU
Paris, , France
Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE
Paris, , France
Hopital F. Mitterand
Pau, , France
Polyclinique Courlancy
Reims, , France
Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire
Rennes, , France
Clinique Saint Jean Languedoc
Toulouse, , France
Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours
Tours, , France
Countries
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References
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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.
Other Identifiers
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NRL994-02/2006 (FFS)
Identifier Type: -
Identifier Source: org_study_id