drugset / Trial / NCT00486512
Chemoprevention of Colorectal Adenomas
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas.
Timeline
- Start
- 2007-06
- Primary completion
- 2010-11
- Completion
- 2010-11
Outcome
Missed primary endpoint
Stopped: “The overall program was terminated”
paper In this analysis, we found no differences between groups in the rate of recurrence (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.61-1.48) PMID 26404953 ↗
paper the combination of calcitriol, aspirin, and calcium carbonate did not prevent recurrence of colorectal adenomas over a 3-year period. PMID 26404953 ↗
Publications
- Pommergaard HC, Burcharth J, Rosenberg J, Raskov H. Aspirin, Calcitriol, and Calcium Do Not Prevent Adenoma Recurrence in a Randomized Controlled Trial. Gastroenterology. 2016 Jan;150(1):114-122.e4. doi: 10.1053/j.gastro.2015.09.010. Epub 2015 Sep 25.
- Carroll C, Cooper K, Papaioannou D, Hind D, Pilgrim H, Tappenden P. Supplemental calcium in the chemoprevention of colorectal cancer: a systematic review and meta-analysis. Clin Ther. 2010 May;32(5):789-803. doi: 10.1016/j.clinthera.2010.04.024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 75 mg | — |
| Subject | Calcitriol | Small molecule | 0.5 mg | — |
| Subject | Calcium carbonate | Other / unclassified | 1250 mg | — |