- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00322062
MOVIPREP® Versus NaP Pivotal Phase III Study
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Besancon, France, 25030
- Hopital Jean Minjoz
-
Colombes, France, 92700
- Hôpital Mourier
-
Lille cedex, France, 59037
- Hopital Huriez
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Limoges, France, 87000
- Hopital Dupuytren
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Lyon, France, 69003
- Hôpital Edouard Herriot
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Marseille Nord cedex 20, France, 13915
- Hopital Nord
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Montelimar cedex, France, 26216
- Centre Hospitalier
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Montfermeil, France, 93370
- Centre Hospitalier Intercommunal
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Montpellier, France, 34000
- Centre Hospitalier De Montpellier Hôpital St Eloi
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Nice cedex 3, France, 06202
- Hopital de l'Archet
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Paris, France, 75018
- Hopital Bichat Claude Bernard
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Paris, France, 75020
- Hôpital Croix Saint Simon
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Paris cedex 10, France, 75475
- Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré
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Paris cedex 14, France, 75379
- Hôpital Cochin
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Strasbourg cedex, France, 67091
- Hôpital Civil / Clinique Medical B
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Toulouse, France, 31403
- Hopital Rangueil
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Tours, France, 37000
- Hôpital Trousseau CHRU
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Vandoeuvre Les Nancy Cedex, France, 54511
- CHU de Brabois
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
2L gut lavage solution
Other Names:
|
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.
|
1 x 45ml solution, BID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome 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.
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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
Outcome Measure |
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patient satisfaction
|
evaluation of the preparation quality using a visual analogue scale
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recording adverse events and clinical tolerance
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alain Bitoun, MD, Hôpital Lariboisère
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRL994-02/2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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