drugset / Trial / NCT04621929
Phentermine/Topiramate for Uric Acid Stones
Phase 2
Completed
19 enrolled
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The investigator proposes an 18 month, feasibility pilot study, randomizing obese and diabetic individuals with pure uric acid nephrolithiasis (UAN) or mixed calcium oxalate (CO) UAN to either phentermine/topiramate or a pragmatic control group who will remain on their standard medication regimen (citrate salts, allopurinol, diet, etc.).
Timeline
- Start
- 2021-03-31
- Primary completion
- 2024-11-14
- Completion
- 2024-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Phentermine | Small molecule | 18.75 mg | Oral |
| Subject | Phentermine | Small molecule | 37.5 mg | Oral |
| Subject | Topiramate | Small molecule | 100 mg | Oral |
| Subject | Topiramate | Small molecule | 150 mg | Oral |
| Background | Allopurinol | Small molecule | — | — |