Efficacy and Safety of mAnniTol in bowel preparation: assessment of adequacy and presence of Intestinal levelS of hydrogen and methane during elective colonoscopy aFter mAnnitol or standard split 2-liter polyethylene glycol solution plus asCorbaTe.
- Conditions
- Subjects scheduled for elective colonoscopy to be prepared and performed according to ESGE (European Society of Gastrointestinal Endoscopy - ESGE) guidelines.MedDRA version: 21.0Level: PTClassification code 10010007Term: ColonoscopySystem Organ Class: 10022891 - InvestigationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2019-002856-18-DE
- Lead Sponsor
- TC s.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 846
1. Ability of patient to consent and provide signed written informed consent
2. Age >= 18 years
3. 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
4. Patients willing and able to complete the entire study and to comply with instructions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 423
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 423
1. 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).
2. Severe renal failure: glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 estimated by means of simplified MDRD equation.
3. Severe heart failure: NYHA Class III-IV.
4. Severe anaemia (Hb = 8 g/dl).
5. 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.
6. Chronic liver disease Child-Pugh class B or C.
7. Electrolyte disturbances (Na, Cl, K, Ca or P out of normal ranges).
8. Recent (< 6 months) symptomatic acute ischemic heart disease.
9. History of significant gastrointestinal surgeries, including colon resection, sub-total colectomy, abdominoperineal resection, de-functioning colostomy or ileostomy, Hartmann’s procedure and other surgeries involving the structure and function of the colon.
10. Use of laxatives, colon motility altering drugs and/or other substances (e.g. simethicone) that can affect bowel cleansing or visibility during colonoscopy within 24 hours prior to colonoscopy.
11. Suspected bowel obstruction or perforation.
12. Indication for partial colonoscopy.
13. Patients who have received an investigational drug or therapy within 5 half-lives of the first visit.
14. Patients previously screened for participation in this study.
15. Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
16. Contraindication to Moviprep® (only for phase III).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method