drugset / Trial / NCT03070574
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Phase 2
Terminated
8 enrolled
Christoph Gasche
Ann-Sofie Backman, MD PhD, Sweden · collabProf. Dr. Gabriela Möslein, Germany · collabProf. Dr. Hans Vasen, The Netherlands · collabProf. Dr. med. Jan Lubinski, Poland · collabProf. Dr. med. Yaron Niv, Israel · collabUniv. Prof. Dr. Judith Karner-Hanusch, Austria · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Multicenter, multinational, randomized, 3-arm, double-blind, phase II clinical study with 2400mg mesalamine, 1200mg mesalamine or placebo for prevention of colorectal neoplasia in Lynch Syndrome patients for 2 years.
Timeline
- Start
- 2017-11-24
- Primary completion
- 2019-04-10
- Completion
- 2019-04-10
Outcome
Outcome not reported
Stopped (Enrollment): “Due to poor patient recruitment and insufficient financing.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesalamine | Small molecule | 1200 mg | — |
| Subject | Mesalamine | Small molecule | 2400 mg | — |