Trial · NCT04621929
Phentermine/Topiramate for Uric Acid Stones
NCT04621929, Phase 2, Completed, University of Florida; results first posted 2026-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phentermine/Topiramate for Uric Acid Stones. Trials, record NCT04621929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04621929
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phentermine/Topiramate for Uric Acid Stones
- NCT number
- NCT04621929
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Obesity, Uric Acid Stones, Type 2 Diabetes Mellitus in Obese, Pre-Diabetes
- Interventions
- Phentermine / Topiramate Oral Product, Citrate Salts, Allopurinol, Diet
- First posted
- 2020-11-09
- Last updated
- 2026-06-15
- Results first posted
- 2026-01-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kidney Stone Size (mm^3) Determined by Non-contrast CAT Scan | Baseline, 18 months | Stone perimeter within each cut of CT image was outlined using semiautomated volume tool (region of interest pen tool, CT software "Visage Imaging") and tallied to calculate stone volume (mm\^3) for each individual stone and recorded from right and left kidney from all study participants at baseline CT and at end of study CT (18 months) |
| Secondary | Weight (kg) | Baseline, 18 months | total weight (baseline and end of study) |
| Secondary | Urinary pH Parameters | Baseline, 18 months | urine pH (baseline and end of study). The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. |
| Secondary | %Hemoglobin A1c | Baseline, 18 months | %A1c (baseline and end of study) |
| Secondary | Urinary Citrate Parameters | Baseline, 18 months | urinary citrate (baseline and end of study) |
| Secondary | Urinary Calcium Parameters | Baseline, 18 months | urinary calcium (baseline and end of study) |
| Secondary | Urinary Uric Acid Supersaturation (SS) | Baseline, 18 months | Urinary uric acid SS (before and end of study). Urinary Uric Acid Supersaturation (SS) is not measured in a specific unit, as it is a ratio. Result below 1: The urine is undersaturated, meaning that crystals are more likely to dissolve than form. Result equal to 1: The urine is in equilibrium with uric acid, so crystals will not grow or shrink. Result above 1: The urine is supersaturated, and the risk for crystals to form and grow is increased. A higher value indicates a greater risk. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kidney Stone Size (mm^3) Determined by Non-contrast CAT Scan | Baseline, 18 months | mm^3 | MEAN | |
| SECONDARY | Weight (kg) | Baseline, 18 months | kg | MEAN | |
| SECONDARY | Urinary pH Parameters | Baseline, 18 months | unitless | MEAN | |
| SECONDARY | %Hemoglobin A1c | Baseline, 18 months | percentage of glycated hemoglobin | MEAN | |
| SECONDARY | Urinary Citrate Parameters | Baseline, 18 months | mg/day | MEAN | |
| SECONDARY | Urinary Calcium Parameters | Baseline, 18 months | mg/day | MEAN | |
| SECONDARY | Urinary Uric Acid Supersaturation (SS) | Baseline, 18 months | unitless | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kidney Stone Size (mm^3) Determined by Non-contrast CAT Scan | Allocated to Intervention/Treatment | Baseline | 6540 | Standard Deviation 10430 | mm^3 |
| Kidney Stone Size (mm^3) Determined by Non-contrast CAT Scan | Allocated to Pragmatic Control | Baseline | 4650 | Standard Deviation 6064 | mm^3 |
| Kidney Stone Size (mm^3) Determined by Non-contrast CAT Scan | Allocated to Intervention/Treatment | End of Study (18 months) | 3120 | Standard Deviation 5158 | mm^3 |
| Kidney Stone Size (mm^3) Determined by Non-contrast CAT Scan | Allocated to Pragmatic Control | End of Study (18 months) | 5041 | Standard Deviation 7043 | mm^3 |
| Weight (kg) | Allocated to Intervention/Treatment | Baseline | 121.4 | Standard Deviation 24 | kg |
| Weight (kg) | Allocated to Pragmatic Control | Baseline | 101.2 | Standard Deviation 23 | kg |
| Weight (kg) | Allocated to Intervention/Treatment | End of Study (18 months) | 111.2 | Standard Deviation 24 | kg |
| Weight (kg) | Allocated to Pragmatic Control | End of Study (18 months) | 104.1 | Standard Deviation 26 | kg |
| Urinary pH Parameters | Allocated to Intervention/Treatment | Baseline | 5.3 | Standard Deviation 0.2 | unitless |
| Urinary pH Parameters | Allocated to Pragmatic Control | Baseline | 5.3 | Standard Deviation 0.2 | unitless |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Allocated to Intervention/Treatment | 13 | |
| Overall Study | STARTED | Allocated to Pragmatic Control | 6 | |
| Overall Study | COMPLETED | Allocated to Intervention/Treatment | 10 | |
| Overall Study | COMPLETED | Allocated to Pragmatic Control | 5 | |
| Overall Study | NOT COMPLETED | Allocated to Intervention/Treatment | 3 | |
| Overall Study | NOT COMPLETED | Allocated to Pragmatic Control | 1 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Kidney Stone Passage | Renal and urinary disorders | Allocated to Intervention/Treatment | 3 | 13 | 3 |
| other | Kidney Stone Passage | Renal and urinary disorders | Allocated to Pragmatic Control | 3 | 6 | 3 |
| other | Kidney Stone Procedure | Renal and urinary disorders | Allocated to Intervention/Treatment | 0 | 13 | 0 |
| other | Kidney Stone Procedure | Renal and urinary disorders | Allocated to Pragmatic Control | 2 | 6 | 2 |
| other | Dizziness | General disorders | Allocated to Intervention/Treatment | 1 | 13 | 1 |
| other | Dizziness | General disorders | Allocated to Pragmatic Control | 0 | 6 | 0 |
| other | Dysgeusia | General disorders | Allocated to Intervention/Treatment | 1 | 13 | 1 |
| other | Dysgeusia | General disorders | Allocated to Pragmatic Control | 0 | 6 | 0 |
| other | Erectile Dysfunction | Renal and urinary disorders | Allocated to Intervention/Treatment | 1 | 13 | 1 |
| other | Erectile Dysfunction | Renal and urinary disorders | Allocated to Pragmatic Control | 0 | 6 | 0 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Allocated to Intervention/Treatment | 0 | 13 |
| Total, all-cause mortality | Allocated to Pragmatic Control | 0 | 6 |
| Total, other adverse events | Allocated to Intervention/Treatment | 12 | 13 |
| Total, other adverse events | Allocated to Pragmatic Control | 5 | 6 |
| Total, serious adverse events | Allocated to Intervention/Treatment | 0 | 13 |
| Total, serious adverse events | Allocated to Pragmatic Control | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DK122317 | Phentermine/tOpiramate to eND Obesity and Uric acid stones Trial (POuND OUT) | CANALES, BENJAMIN K | UNIVERSITY OF FLORIDA | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2020 to 2021 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Allocated to Intervention/Treatment vs Allocated to Pragmatic Control: deaths from any cause | Trial comparisons |
| Allocated to Intervention/Treatment vs Allocated to Pragmatic Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04621929
GET https://conductscience.org/api/trials/v1/NCT04621929/results?page=2