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Phentermine/Topiramate for Uric Acid Stones

NCT04621929 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-01-30

Study results available
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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.).

Conditions

  • Obesity
  • Uric Acid Stones
  • Type 2 Diabetes Mellitus in Obese
  • Pre-Diabetes

Interventions

DRUG

Phentermine / Topiramate Oral Product

All participants in the experimental group will receive oral generic tablet phentermine (18.75 or 37.5 mg dose) and topiramate (daily 100 mg or 150 mg dose)

COMBINATION_PRODUCT

Citrate Salts, Allopurinol, Diet

Control participants will complete initial visit requirements and study enrollment and will be maintained on their current therapy.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Benjamin Canales, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2024-11-14
Completion
2024-11-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04621929 on ClinicalTrials.gov