MOVIPREP® Versus NaP Pivotal Phase III Study
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|ClinicalTrials.gov Identifier: NCT00322062|
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : April 16, 2008
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate Drug: Sodium Phosphate Solution||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||April 2002|
|Study Completion Date :||March 2003|
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
2L gut lavage solution
Other Name: MOVIPREP®
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.
Drug: Sodium Phosphate Solution
1 x 45ml solution, BID
Other Name: Fleet Phospho Soda®
- 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.
- evaluation of the preparation quality using a visual analogue scale
- recording adverse events and clinical tolerance
- patient satisfaction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322062
|Principal Investigator:||Alain Bitoun, MD||Hôpital Lariboisère|