drugset / Trial / NCT03300570
Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers
RandomizedParallel-groupDouble-blindPrevention
Summary
This phase I trial studies how well dolcanatide works in preventing colorectal cancer in healthy participants. Dolcanatide is similar to a natural hormone released into the intestine. It is thought that people who have low levels of the hormone are more likely to get colon cancer. It may be possible to prevent colon cancer by giving a drug that is similar to the hormone, such as dolcanatide.
Timeline
- Start
- 2018-07-27
- Primary completion
- 2019-01-02
- Completion
- 2021-05-17
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm B (Dolcanatide) vs Arm A (Placebo); p = 0.15; Wilcoxon (Mann-Whitney) NCT03300570 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolcanatide | Protein / enzyme biologic | 27 mg | Oral |