Clinical trial NCT00322062: MOVIPREP® Versus NaP Pivotal Phase III Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Keywords: Colon cleansing
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2006-05-04
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
measure: 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 outcomes:
measure: evaluation of the preparation quality using a visual analogue scale
measure: recording adverse events and clinical tolerance
measure: patient satisfaction
Other outcomes:
Locations:
city: Besancon
country: France
facility: Hôpital Jean Minjoz
city: Colombes
country: France
facility: Hôpital Mourier
city: Lille cedex
country: France
facility: Hôpital Huriez
city: Limoges
country: France
facility: Hôpital Dupuytren
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille Nord cedex 20
country: France
facility: Hôpital Nord
city: Montelimar cedex
country: France
facility: Centre Hospitalier
city: Montfermeil
country: France
facility: Centre Hospitalier Intercommunal
city: Montpellier
country: France
facility: Centre Hospitalier De Montpellier Hôpital St Eloi
city: Nice cedex 3
country: France
facility: Hôpital De L'Archet
city: Paris cedex 10
country: France
facility: Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré
city: Paris cedex 14
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Bichat Claude Bernard
city: Paris
country: France
facility: Hôpital Croix Saint Simon
city: Strasbourg cedex
country: France
facility: Hôpital Civil / Clinique Medical B
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Tours
country: France
facility: Hôpital Trousseau CHRU
city: Vandoeuvre Les Nancy Cedex
country: France
facility: CHU De Brabois
Study officials:
affiliation: Hôpital Lariboisère
name: Alain Bitoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fordtran JS, Santa Ana CA, Cleveland MvB. A low-sodium solution for gastrointestinal lavage. Gastroenterology. 1990 Jan;98(1):11-6. doi: 10.1016/0016-5085(90)91284-d.