MOVIPREP® Versus NaP Pivotal Phase III Study

NCT00322062 | Completed Phase 3

• 1 other identifier: NRL994-02/2001
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 18

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.

Conditions

Colonoscopy

Keywords

Colon cleansing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• evaluation of the preparation quality using a visual analogue scale

• recording adverse events and clinical tolerance

• patient satisfaction

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate DRUG

2L gut lavage solution

Also known as: MOVIPREP®

1

Sodium Phosphate Solution DRUG

1 x 45ml solution, BID

Also known as: Fleet Phospho Soda®

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Norgine: lead

Study Sites (18)

Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Mourier

Colombes, 92700, France

Location

Hôpital Huriez

Lille, 59037, France

Location

Hôpital Dupuytren

Limoges, 87000, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hôpital Nord

Marseille Nord Cedex 20, 13915, France

Location

Centre Hospitalier

Montélimar, 26216, France

Location

Centre Hospitalier Intercommunal

Montfermeil, 93370, France

Location

Centre Hospitalier De Montpellier Hôpital St Eloi

Montpellier, 34000, France

Location

Hôpital De L'Archet

Nice, 06202, France

Location

Hôpital Bichat Claude Bernard

Paris, 75018, France

Location

Hôpital Croix Saint Simon

Paris, 75020, France

Location

Hôpital Cochin

Paris, 75379, France

Location

Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré

Paris, 75475, France

Location

Hôpital Civil / Clinique Medical B

Strasbourg, 67091, France

Location

Hôpital Rangueil

Toulouse, 31403, France

Location

Hôpital Trousseau CHRU

Tours, 37000, France

Location

CHU De Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• 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.

  PMID: 2293568 BACKGROUND

MeSH Terms

Interventions

MoviPrep

Study Officials

• Alain Bitoun, MD

  Hôpital Lariboisère

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2006
• First Posted: May 4, 2006
• Study Start: April 1, 2002
• Study Completion: March 1, 2003
• Last Updated: April 16, 2008

Record last verified: 2008-04

Locations

FR (18)