MOVIPREP® Versus NaP Pivotal Phase III Study

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322062
• Other study ID #: NRL994-02/2001
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2006
• Last updated: April 15, 2008
• Start date: April 2002
• Est. completion date: March 2003

Study information

• Verified date: April 2008
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
2L gut lavage solution
• Sodium Phosphate Solution
1 x 45ml solution, BID

Locations

Country	Name	City	State
France	Hôpital Jean Minjoz	Besancon
France	Hôpital Mourier	Colombes
France	Hôpital Huriez	Lille cedex
France	Hôpital Dupuytren	Limoges
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Nord	Marseille Nord cedex 20
France	Centre Hospitalier	Montelimar cedex
France	Centre Hospitalier Intercommunal	Montfermeil
France	Centre Hospitalier De Montpellier Hôpital St Eloi	Montpellier
France	Hôpital De L'Archet	Nice cedex 3
France	Hôpital Bichat Claude Bernard	Paris
France	Hôpital Croix Saint Simon	Paris
France	Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré	Paris cedex 10
France	Hôpital Cochin	Paris cedex 14
France	Hôpital Civil / Clinique Medical B	Strasbourg cedex
France	Hôpital Rangueil	Toulouse
France	Hôpital Trousseau CHRU	Tours
France	CHU De Brabois	Vandoeuvre Les Nancy Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

France, 

References & Publications (1)

Fordtran JS, Santa Ana CA, Cleveland MvB. A low-sodium solution for gastrointestinal lavage. Gastroenterology. 1990 Jan;98(1):11-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	evaluation of the preparation quality using a visual analogue scale
Secondary	recording adverse events and clinical tolerance
Secondary	patient satisfaction