MOVIPREP® Versus NaP Pivotal Phase III Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-03-31

Brief Summary

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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

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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.

Conditions

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Colonoscopy

Keywords

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Colon cleansing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

Intervention Type DRUG

2L gut lavage solution

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.

Group Type ACTIVE_COMPARATOR

Sodium Phosphate Solution

Intervention Type DRUG

1 x 45ml solution, BID

Interventions

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macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

2L gut lavage solution

Intervention Type DRUG

Sodium Phosphate Solution

1 x 45ml solution, BID

Intervention Type DRUG

Other Intervention Names

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MOVIPREP® Fleet Phospho Soda®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Norgine

Principal Investigators

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Alain Bitoun, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Lariboisère

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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.

Reference Type BACKGROUND

PMID: 2293568 (View on PubMed)

Other Identifiers

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NRL994-02/2001

Identifier Type: -

Identifier Source: org_study_id

MOVIPREP® Versus NaP Pivotal Phase III Study

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

2

Sodium Phosphate Solution

Interventions

macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

Sodium Phosphate Solution

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Norgine

Responsible Party

Principal Investigators

Alain Bitoun, MD

Locations

Hôpital Jean Minjoz

Hôpital Mourier

Hôpital Huriez

Hôpital Dupuytren

Hôpital Edouard Herriot

Hôpital Nord

Centre Hospitalier

Centre Hospitalier Intercommunal

Centre Hospitalier De Montpellier Hôpital St Eloi

Hôpital De L'Archet

Hôpital Bichat Claude Bernard

Hôpital Croix Saint Simon

Hôpital Cochin

Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré

Hôpital Civil / Clinique Medical B

Hôpital Rangueil

Hôpital Trousseau CHRU

CHU De Brabois

Countries

References

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.

Other Identifiers

NRL994-02/2001