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CompletedNCT00605228NORMOUpdated Jan 30, 2008

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

A Phase 4 interventional study of MOVIPREP and COLOPEG in Gastrointestinal Diseases, sponsored by Norgine. Completed at 21 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-01-30.

Sponsored by Norgine · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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®.
Read the 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).

02

Conditions studied

  • Gastrointestinal Diseases
03

In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's enrollment of 400 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Norgine is the lead sponsor of 52 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

    -

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    1

    Drug: MOVIPREP

  • Active comparator
    2

    Drug: COLOPEG

Interventions

  • DrugMOVIPREP

    2L Drug

  • DrugCOLOPEG

    4L Drug

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

21 sites
  • Centre Hospitalier Du Mans
    Le Mans, Lemans 72000, 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
    Creteil, 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 d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS
    Nancy, 54511, 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
  • Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE
    Rouen, 76031, France
  • Clinique Saint Jean Languedoc
    Toulouse, 31400, France
  • Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours
    Tours, 37000, France
08

References and documents

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. PubMed 17094774 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00605228
Lead sponsor
Norgine
Collaborators
International Clinical Trials Association
First posted
Jan 30, 2008
Start date
May 2007
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Jan 30, 2008

Study contacts

Thierry PONCHON, MD
principal investigator · HOPITAL EDOUARD HERRIOT

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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