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MOVIPREP® Versus NaP Pivotal Phase III Study

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00322062
First received: May 2, 2006
Last updated: April 15, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Colonoscopy
Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
Drug: Sodium Phosphate Solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • 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.
  • 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:
  • evaluation of the preparation quality using a visual analogue scale
  • recording adverse events and clinical tolerance
  • patient satisfaction

Enrollment: 340
Study Start Date: April 2002
Estimated Study Completion Date: March 2003
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322062

Locations
France
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
Hôpital Croix Saint Simon
Paris, France, 75020
Hôpital Bichat Claude Bernard
Paris, France, 75018
Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré
Paris cedex 10, France, 75475
Hôpital Cochin
Paris cedex 14, France, 75379
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
Norgine
Investigators
Principal Investigator: Alain Bitoun, MD Hôpital Lariboisère
  More Information

Publications:
Responsible Party: Dr Marc Halphen, Norgine
ClinicalTrials.gov Identifier: NCT00322062     History of Changes
Other Study ID Numbers: NRL994-02/2001
Study First Received: May 2, 2006
Last Updated: April 15, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Norgine:
Colon cleansing

Additional relevant MeSH terms:
Ascorbic Acid
Pharmaceutical Solutions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014