MOVIPREP® Versus NaP Pivotal Phase III Study

Last updated: April 15, 2008
Sponsor: Norgine
Overall Status: Completed

Phase

3

Condition

Colon Cancer Screening

Treatment

N/A

Clinical Study ID

NCT00322062
NRL994-02/2001
  • Ages 18-75
  • All Genders

Study Summary

The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male or female, out and inpatients to be at least 18 years old and <75 years old sentto the endoscopic ward for diagnostic or therapeutic colonoscopy

  • willing and able to complete the entire procedure and to comply with studyinstructions

  • females of childbearing potential must employ an adequate method of contraception.

Exclusion

Exclusion Criteria:

  • age <18 or > 75 years old

  • ileus

  • suspected intestinal occlusion or perforation

  • toxic or congenital megacolon

  • history of colonic resection

  • patients with Crohn's disease or ulcerative colitis

  • congestive heart failure NYHA III or IV

  • documented renal insufficiency history with creatinine >170µmol/l

  • known hypersensitivity to polyethylene glycols or Na phosphate and/or vitamin C

  • concurrent participation in an investigational drug study or participation within 90days of study entry

  • females who are pregnant, or planning a pregnancy. Females of childbearing potentialnot using reliable methods of contraception

  • subject has a condition or is in a situation which in the investigators opinion mayput the subject at significant risk, may confound the study results, or may interferesignificantly

Study Design

Total Participants: 340
Study Start date:
April 01, 2002
Estimated Completion Date:
March 31, 2003

Study Description

Multicentric (15 centres), prospective, randomised, single-blinded phase III pivotal study in patients undergoing a colonoscopy. Gut cleansing will be performed using 2 litres of NRL994 gut lavage solution with 1 litre (or more) of extra clear liquids or 2 x 45 ml of a sodium phosphate solution plus 2 litres (or more) of extra clear liquids the day before colonoscopy. Patients requiring a morning colonoscopy who fulfil the inclusion criteria, will be randomised. One of the two tested products will be delivered by a pharmacist, blindly from the gastroenterologist. The assigned product will be taken the day before the coloscopy according to the information leaflet. Efficacy of the two tested preparations will be measured on video-tape record of each colonoscopy by a final grading i.e. "the overall quality of colonoscopy prep" by an gastroenterologist expert. A standardised patient questionnaire administered by a nurse on the morning before colonoscopy will assess clinical tolerance and acceptability (satisfaction) of the prep. A baseline blood sampling will be withdrew before intake of the preparation and one more blood sample will be performed after the intake on the morning, before the coloscopy.

After the coloscopy, as the gastroenterologist gives the result of the coloscopy , a last visit is performed.

Connect with a study center

  • Hôpital Jean Minjoz

    Besancon, 25030
    France

    Site Not Available

  • Hôpital Mourier

    Colombes, 92700
    France

    Site Not Available

  • Hôpital Huriez

    Lille cedex, 59037
    France

    Site Not Available

  • Hôpital Dupuytren

    Limoges, 87000
    France

    Site Not Available

  • Hôpital Edouard Herriot

    Lyon, 69003
    France

    Site Not Available

  • Hôpital Nord

    Marseille Nord cedex 20, 13915
    France

    Site Not Available

  • Centre Hospitalier

    Montelimar cedex, 26216
    France

    Site Not Available

  • Centre Hospitalier Intercommunal

    Montfermeil, 93370
    France

    Site Not Available

  • Centre Hospitalier De Montpellier Hôpital St Eloi

    Montpellier, 34000
    France

    Site Not Available

  • Hôpital De L'Archet

    Nice cedex 3, 06202
    France

    Site Not Available

  • Hôpital Bichat Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • Hôpital Croix Saint Simon

    Paris, 75020
    France

    Site Not Available

  • Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré

    Paris cedex 10, 75475
    France

    Site Not Available

  • Hôpital Cochin

    Paris cedex 14, 75379
    France

    Site Not Available

  • Hôpital Civil / Clinique Medical B

    Strasbourg cedex, 67091
    France

    Site Not Available

  • Hôpital Rangueil

    Toulouse, 31403
    France

    Site Not Available

  • Hôpital Trousseau CHRU

    Tours, 37000
    France

    Site Not Available

  • CHU De Brabois

    Vandoeuvre Les Nancy Cedex, 54511
    France

    Site Not Available

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