drugset / Trial / NCT04759885
Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®
RandomizedParallel-groupSingle-blindDiagnostic
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 .
Timeline
- Start
- 2020-06-18
- Primary completion
- 2021-07-16
- Completion
- 2021-07-16
Publications
- Tontini GE, Spada C, Uebel P, Cannizzaro R, Ciprandi G, Vecchi M. Assessment of Patient-Reported Outcome Measures in Patients Undergoing Bowel Preparation With Mannitol for Colonoscopy: The SATISFACTION Study. JGH Open. 2025 Aug 7;9(8):e70237. doi: 10.1002/jgh3.70237. eCollection 2025 Aug.
- Carnovali M, Spada C, Uebel P, Bocus P, Cannizzaro R, Cavallaro F, Cesana BM, Cesaro P, Costamagna G, Di Paolo D, Ferrari AP, Hinkel C, Kashin S, Massella A, Melnikova E, Orsatti A, Ponchon T, Prada A, Radaelli F, Sferrazza S, Soru P, Testoni PA, Tontini GE, Vecchi M, Fiori G; SATISFACTION Study Group. Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study. Clin Transl Sci. 2023 May;16(5):759-769. doi: 10.1111/cts.13486. Epub 2023 Feb 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Moviprep | Other / unclassified | 2000 ml | Oral |
| Subject | NTC015 | Unknown | 50 g | Oral |
| Subject | NTC015 | Unknown | 100 g | Oral |
| Subject | NTC015 | Unknown | 150 g | Oral |
Indications
No indication recorded.