Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison W… (NCT04759885) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®
France, Germany886 participantsStarted 2020-06-18
Plain-language summary
The purpose of this dose finding/comparative efficacy study is to first single out the most appropriate dose of mannitol for bowel preparation (phase II) and, subsequently, demonstrate the non-inferiority of the efficacy of single dose mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation for colonoscopy .
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability of patient to consent and provide signed written informed consent
✓. Age ≥ 18 years
✓. Males and females scheduled for elective (screening, surveillance or diagnostic) colonoscopy to be prepared and performed according to the European Society of Gastrointestinal Endoscopy (ESGE) Guideline
✓. Patients willing and able to complete the entire study and to comply with instructions
Exclusion criteria
✕. Pregnancy or breastfeeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and must practice one of the following methods of birth control throughout the study period (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy): oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom; intrauterine device in combination with a condom; double barrier method (condom and occlusive cap with spermicidal foam/gel/film/cream/suppository).
✕. Severe renal failure: glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2 estimated by means of simplified MDRD equation.
✕. Severe heart failure: NYHA Class III-IV.
✕. Severe anaemia (Hb ≤ 8 g/dl).
✕. Severe acute and chronically active Inflammatory Bowel Disease; patients in clinical remission (Crohn's Disease Activity Index - CDAI \< 150 for Crohn Disease and Partial Mayo Score ≤ 2 for Ulcerative Colitis) are allowed.
✕
What they're measuring
1
Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
2
Phase III - Non-inferiority: Proportion of Patients With Adequate Bowel Cleansing
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed, at least 4 hours after end of intake, following product instruction as per protocol