Status:
COMPLETED
Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®
Lead Sponsor:
NTC srl
Conditions:
Elective Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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-inferio...
Detailed Description
Study Start and Study Completion dates relative to the Phase II/III are reported here: Phase II (Patients n. 183) * Date of first enrolment: 18 June 2020 * Date LPLV: 12 November 2020 Phase III (Pa...
Eligibility Criteria
Inclusion
- 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
- 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.
- Chronic liver disease Child-Pugh class B or C.
- Electrolyte disturbances (Na, Cl, K, Ca or P out of normal ranges).
- Recent (\< 6 months) symptomatic acute ischemic heart disease.
- 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.
- 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.
- Suspected bowel obstruction or perforation.
- Indication for partial colonoscopy.
- Patients who have received an investigational drug or therapy within 5 half-lives of the first visit.
- Patients previously screened for participation in this study.
- Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
- Contraindication to Moviprep® (only for phase III).
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2021
Estimated Enrollment :
886 Patients enrolled
Trial Details
Trial ID
NCT04759885
Start Date
June 18 2020
End Date
July 16 2021
Last Update
December 8 2025
Active Locations (35)
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1
Centre Hospitalier Henri Duffaut
Avignon, France
2
Hospices civils de Lyon
Lyon, France
3
Hôpital Edouard Herriot
Lyon, France
4
Centre Hospitalier Universitaire de Montpellier
Montpellier, France