Colonoscopy
Conditions
Keywords
Colon cleansing
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.
Interventions
2L gut lavage solution
DRUGSodium Phosphate Solution
1 x 45ml solution, BID
Sponsors
Norgine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| evaluation of the preparation quality using a visual analogue scale | — |
| recording adverse events and clinical tolerance | — |
| patient satisfaction | — |
Countries
France
Outcome results
None listed