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Trial record 2 of 2 for:    correct dupuytren

MOVIPREP® Versus NaP Pivotal Phase III Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00322062
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : April 16, 2008
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate Drug: Sodium Phosphate Solution Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Single-Blinded Multicentric and Pivotal Phase III Study Comparing the Efficacy, Safety and Acceptability of a New 2 Litres Gut Lavage Solution NRL994 Versus a Sodium Phosphate Solution for Colonoscopy Preparation
Study Start Date : April 2002
Estimated Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
1 pack (contains 4 (2 x PEG + E/"P" + 2 x Vitamin C/"C") sachets)= 2L NRL994 . 2 sachets (one of each) will be dissolved in 1L of water. Each litre will be drunk within 1 hour. Furthermore, at least 1000ml (or more) of any additional clear fluid (except milk) has to be drunk after the 2L of NRL994.
Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
2L gut lavage solution
Other Name: MOVIPREP®
Active Comparator: 2
1 pack consists of 2 flasks of 45ml. Each flask has to be dissolved within 125ml of water. Each intake of NaP solution has to be preceded and followed by 250ml (or more if necessary)of clear liquids(excluding milk)and a delay of at least 12 hours between the intake of the 2 x 45ml of NaP solution has to be completed. In addition, 750ml more of clear liquids (excluding milk)or more if needed must be drunk between the 2 intakes.
Drug: Sodium Phosphate Solution
1 x 45ml solution, BID
Other Name: Fleet Phospho Soda®

Primary Outcome Measures :
  1. efficacy will be measured and graded using video-taped record of each colonoscopy for cleansing in a 0 - 4 grade scale for each of the predefined colon areas by an endoscopist.
  2. Grades A or B means a good or correct preparation and are considered as a success whilst C or D are considered as a failed preparation.

Secondary Outcome Measures :
  1. evaluation of the preparation quality using a visual analogue scale
  2. recording adverse events and clinical tolerance
  3. patient satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male or female, out and inpatients to be at least 18 years old and <75 years old sent to the endoscopic ward for diagnostic or therapeutic colonoscopy
  • willing and able to complete the entire procedure and to comply with study instructions
  • females of childbearing potential must employ an adequate method of contraception.

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 90 days of study entry
  • females who are pregnant, or planning a pregnancy. Females of childbearing potential not using reliable methods of contraception
  • subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322062

Hôpital Jean Minjoz
Besancon, France, 25030
Hôpital Mourier
Colombes, France, 92700
Hôpital Huriez
Lille cedex, France, 59037
Hôpital Dupuytren
Limoges, France, 87000
Hôpital Edouard Herriot
Lyon, France, 69003
Hôpital Nord
Marseille Nord cedex 20, France, 13915
Centre Hospitalier
Montelimar cedex, France, 26216
Centre Hospitalier Intercommunal
Montfermeil, France, 93370
Centre Hospitalier De Montpellier Hôpital St Eloi
Montpellier, France, 34000
Hôpital De L'Archet
Nice cedex 3, France, 06202
Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré
Paris cedex 10, France, 75475
Hôpital Cochin
Paris cedex 14, France, 75379
Hôpital Bichat Claude Bernard
Paris, France, 75018
Hôpital Croix Saint Simon
Paris, France, 75020
Hôpital Civil / Clinique Medical B
Strasbourg cedex, France, 67091
Hôpital Rangueil
Toulouse, France, 31403
Hôpital Trousseau CHRU
Tours, France, 37000
CHU De Brabois
Vandoeuvre Les Nancy Cedex, France, 54511
Sponsors and Collaborators
Principal Investigator: Alain Bitoun, MD Hôpital Lariboisère

Responsible Party: Dr Marc Halphen, Norgine
ClinicalTrials.gov Identifier: NCT00322062     History of Changes
Other Study ID Numbers: NRL994-02/2001
First Posted: May 4, 2006    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008

Keywords provided by Norgine:
Colon cleansing

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ascorbic Acid
Polyethylene glycol 3350
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances
Gastrointestinal Agents