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Sponsored by: |
Norgine |
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Information provided by: | Norgine |
ClinicalTrials.gov Identifier: | NCT00322062 |
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.
Condition | Intervention | Phase |
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Colonoscopy |
Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate Drug: Sodium Phosphate Solution |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy 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 |
Enrollment: | 340 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | March 2003 |
Arms | Assigned Interventions |
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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.
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Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
2L gut lavage solution
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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.
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Drug: Sodium Phosphate Solution
1 x 45ml solution, BID
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Unité Endoscopies Digestives, Hôpital Lariboisière, 2 rue Ambroise Paré | |
Paris cedex 10, France, 75475 | |
Hôpital Nord | |
Marseille Nord cedex 20, France, 13915 | |
Hôpital Huriez | |
Lille cedex, France, 59037 | |
Hôpital Cochin | |
Paris cedex 14, France, 75379 | |
Hôpital Mourier | |
Colombes, France, 92700 | |
Hôpital Civil / Clinique Medical B | |
Strasbourg cedex, France, 67091 | |
Hôpital Rangueil | |
Toulouse, France, 31403 | |
CHU De Brabois | |
vandoeuvre les nancy cedex, France, 54511 | |
Centre Hospitalier | |
Montelimar cedex, France, 26216 | |
Hôpital De L'Archet | |
Nice cedex 3, France, 06202 | |
Centre Hospitalier Intercommunal | |
montfermeil, France, 93370 | |
Hôpital Dupuytren | |
Limoges, France, 87000 | |
Hôpital Bichat Claude Bernard | |
Paris, France, 75018 | |
Hôpital Trousseau CHRU | |
Tours, France, 37000 | |
Centre Hospitalier De Montpellier Hôpital St Eloi | |
Montpellier, France, 34000 | |
Hôpital Jean Minjoz | |
Besancon, France, 25030 | |
Hôpital Croix Saint Simon | |
Paris, France, 75020 | |
Hôpital Edouard Herriot | |
lyon, France, 69003 |
Principal Investigator: | Alain Bitoun, MD | Hôpital Lariboisère |
Responsible Party: | Norgine ( Dr Marc Halphen ) |
Study ID Numbers: | NRL994-02/2001 |
Study First Received: | May 2, 2006 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00322062 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Colon cleansing |
Laxatives Sodium phosphate Antioxidants Vitamins |
Cathartics Trace Elements Micronutrients Ascorbic Acid |
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Gastrointestinal Agents Cathartics Protective Agents |
Pharmacologic Actions Sodium phosphate Vitamins Therapeutic Uses Micronutrients Ascorbic Acid |