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| Name | Class |
|---|---|
| International Clinical Trials Association | OTHER |
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Primary:
- To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.
Secondary:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOVIPREP | Drug | 2L Drug |
| |
| COLOPEG |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Thierry PONCHON, MD | HOPITAL EDOUARD HERRIOT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Du Mans | Le Mans | Lemans | 72000 | France | ||
| Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17094774 | Background | 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. |
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| Drug |
4L Drug |
|
| Nancy |
| Nancy |
| 54511 |
| France |
| Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE | Rouen | Rouen | 76031 | France |
| Cabinet de gatsro-entérologie | Anglet | 64600 | France |
| Cabinet de gastroentérologie | Aubagne | 13400 | France |
| Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON | Avignon | 84029 | France |
| Clinique de La Châtaigneraie | Beaumont | 63110 | France |
| Cabinet de gastro-entérologie | Bordeaux | 33300 | France |
| Clinique Saint Martin | Caen | 14000 | France |
| Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL | Créteil | 94000 | France |
| Centre Des Maladies Du Foie Et de L'Appareil Digestif | Irigny | 69540 | France |
| Cabinet de gastroentérologie | Les Sables-d'Olonne | 85100 | France |
| Cabinet Medical Jemmapes | Lille | 59800 | France |
| Service de Gastroentérologie, HOPITAL DE L'ARCHET | Nice | 06200 | France |
| Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU | Paris | 75015 | France |
| Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE | Paris | 75475 | France |
| Hopital F. Mitterand | Pau | 64000 | France |
| Polyclinique Courlancy | Reims | 51100 | France |
| Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire | Rennes | 35000 | France |
| Clinique Saint Jean Languedoc | Toulouse | 31400 | France |
| Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours | Tours | 37000 | France |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
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