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
Overview
- Phase
- Phase 3
- Intervention
- macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
- Conditions
- Colonoscopy
- Sponsor
- Norgine
- Enrollment
- 340
- Locations
- 18
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
- •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
Arms & Interventions
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.
Intervention: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
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.
Intervention: Sodium Phosphate Solution
Outcomes
Primary Outcomes
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
- evaluation of the preparation quality using a visual analogue scale
- recording adverse events and clinical tolerance
- patient satisfaction