drugset / Trial / NCT05465889
Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy
Phase 3
Completed
348 enrolled
Changhai Hospital
Beijing Hospital · collabChina-japan Friendship Hospital, Jilin University · collabHebei Provincial People's Hospital · collabHenan Provincial People's Hospital · collabShandong University Qilu Hospital · collabShanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collabShanghai Hospital of Integrated Traditional Chinese and Western Medicine · collabThe First Affiliated Hospital of Nanchang University · collabZhongshan Hospital Xiamen University · collab
RandomizedParallel-groupQuadruple-blindDiagnostic
Summary
To evaluate whether oral sulfate solution used for colon cleaning in adults prior to colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy
Timeline
- Start
- 2019-05-15
- Primary completion
- 2020-01-09
- Completion
- 2020-03-15
Publications
- Background Kluge MA, Williams JL, Wu CK, Jacobson BC, Schroy PC 3rd, Lieberman DA, Calderwood AH. Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy. Gastrointest Endosc. 2018 Mar;87(3):744-751. doi: 10.1016/j.gie.2017.06.012. Epub 2017 Jun 23.
- Background Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
- Pan P, Zhao S, Wang S, Song Y, Gu L, Chen Y, Zhao J, Lu L, Li X, Xu H, Liu G, Li Y, Xu L, Wang J, Li Z, Bai Y. Comparison of the efficacy and safety of an oral sulfate solution and 3-L polyethylene glycol on bowel preparation before colonoscopy: a phase III multicenter randomized controlled trial. Gastrointest Endosc. 2023 Dec;98(6):977-986.e14. doi: 10.1016/j.gie.2023.06.070. Epub 2023 Jul 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oral sulfate solution | Unknown | 177 ml | Oral |
| Comparator | Polyethylene Glycol Electrolyte | Unknown | 3000 ml | Oral |
Indications
No indication recorded.