Trial · NCT02246673
RDEA3170 and Febuxostat Combination Study in Gout Subjects
NCT02246673, Phase 2, Completed, Ardea Biosciences, Inc.; results first posted 2017-07-27
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. RDEA3170 and Febuxostat Combination Study in Gout Subjects. Trials, record NCT02246673. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02246673
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RDEA3170 and Febuxostat Combination Study in Gout Subjects
- NCT number
- NCT02246673
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Ardea Biosciences, Inc.
- Conditions
- Gout
- Interventions
- RDEA3170 15 mg, RDEA3170 10 mg, RDEA3170 2.5, RDEA3170 5 mg, Febuxostat 40 mg, Febuxostat 80 mg
- First posted
- 2014-09-23
- Last updated
- 2017-07-27
- Results first posted
- 2017-07-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Urate Maximum Percentage (%) Change (Emax, CB) | 28 days | Maximum observed percentage (%) change from baseline in serum urate concentrations. |
| Primary | Urine Uric Acid % Change (0-24h) (Aeur, CB) | 28 days | Percentage (%) change from baseline in the amount of uric acid recovered in urine. |
| Primary | Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB) | 28 days | Percentage (%) change from baseline in renal clearance of uric acid. |
| Primary | Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB) | 28 days | Percentage (%) change from baseline in fractional excretion of uric acid. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Days 7 to 28 | Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma |
| Secondary | Time of Occurrence of Maximum Observed Concentration (Tmax) | Days 7 to 28 | Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma |
| Secondary | Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) | Days 7 to 28 | AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma |
| Secondary | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) | Days 7 to 28 | AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma |
| Secondary | Apparent Terminal Half-life (t1/2) | Days 7 to 28 | t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma |
| Secondary | Incidence of Treatment-Emergent Adverse Events | 10 weeks |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Urate Maximum Percentage (%) Change (Emax, CB) | 28 days | Percentage (%) | MEAN | |
| PRIMARY | Urine Uric Acid % Change (0-24h) (Aeur, CB) | 28 days | Percentage (%) | MEAN | |
| PRIMARY | Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB) | 28 days | Percentage (%) | MEAN | |
| PRIMARY | Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB) | 28 days | Percentage (%) | MEAN | |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) | Days 7 to 28 | ng/mL | GEOMETRIC_MEAN | |
| SECONDARY | Time of Occurrence of Maximum Observed Concentration (Tmax) | Days 7 to 28 | hr | MEDIAN | |
| SECONDARY | Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) | Days 7 to 28 | ng·hr/mL | GEOMETRIC_MEAN | |
| SECONDARY | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) | Days 7 to 28 | ng·hr/mL | GEOMETRIC_MEAN | |
| SECONDARY | Apparent Terminal Half-life (t1/2) | Days 7 to 28 | hr | GEOMETRIC_MEAN | |
| SECONDARY | Incidence of Treatment-Emergent Adverse Events | 10 weeks | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | Febuxostat 40 mg | -43.5 | Standard Error 1.10 | Percentage (%) | |
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | Febuxostat 80 mg | -55.6 | Standard Error 1.37 | Percentage (%) | |
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | RDEA3170 10 mg + Febuxostat 40 mg | -70.4 | Standard Error 1.35 | Percentage (%) | |
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | RDEA3170 10 mg + Febuxostat 80 mg | -79.1 | Standard Error 2.53 | Percentage (%) | |
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | RDEA3170 15 mg + Febuxostat 40 mg | -74.9 | Standard Error 1.18 | Percentage (%) | |
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | RDEA3170 15 mg + Febuxostat 80 mg | -82.4 | Standard Error 1.76 | Percentage (%) | |
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | RDEA3170 5 mg + Febuxostat 40 mg | -59.4 | Standard Error 2.81 | Percentage (%) | |
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | RDEA3170 5 mg + Febuxostat 80 mg | -66.7 | Standard Error 2.32 | Percentage (%) | |
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | RDEA3170 2.5 mg + Febuxostat 40 mg | -52.5 | Standard Error 2.51 | Percentage (%) | |
| Serum Urate Maximum Percentage (%) Change (Emax, CB) | RDEA3170 2.5 mg + Febuxostat 80 mg | -62.7 | Standard Error 2.69 | Percentage (%) |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 14 | |
| Overall Study | STARTED | Cohort 2 | 12 | |
| Overall Study | STARTED | Cohort 3 | 12 | |
| Overall Study | STARTED | Cohort 4 | 14 | |
| Overall Study | STARTED | Cohort 5 | 12 | |
| Overall Study | COMPLETED | Cohort 1 | 13 | |
| Overall Study | COMPLETED | Cohort 2 | 12 | |
| Overall Study | COMPLETED | Cohort 3 | 12 | |
| Overall Study | COMPLETED | Cohort 4 | 12 | |
| Overall Study | COMPLETED | Cohort 5 | 11 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events69
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 | Dyspepsia | Gastrointestinal disorders | Febuxostat 40 mg | 1 | 61 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Febuxostat 80 mg | 0 | 51 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Overall RDEA3170 + Febuxostat Combination | 2 | 62 | 2 |
| other | Aphthous Stomatitis | Gastrointestinal disorders | Febuxostat 40 mg | 0 | 61 | 0 |
| other | Aphthous Stomatitis | Gastrointestinal disorders | Febuxostat 80 mg | 0 | 51 | 0 |
| other | Aphthous Stomatitis | Gastrointestinal disorders | Overall RDEA3170 + Febuxostat Combination | 1 | 62 | 2 |
| other | Constipation | Gastrointestinal disorders | Febuxostat 40 mg | 1 | 61 | 1 |
| other | Constipation | Gastrointestinal disorders | Febuxostat 80 mg | 0 | 51 | 0 |
| other | Constipation | Gastrointestinal disorders | Overall RDEA3170 + Febuxostat Combination | 0 | 62 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Febuxostat 40 mg | 0 | 61 | 0 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Febuxostat 40 mg | ||
| Total, all-cause mortality | Febuxostat 80 mg | ||
| Total, all-cause mortality | Overall RDEA3170 + Febuxostat Combination | ||
| Total, other adverse events | Febuxostat 40 mg | 3 | 61 |
| Total, other adverse events | Febuxostat 80 mg | 8 | 51 |
| Total, other adverse events | Overall RDEA3170 + Febuxostat Combination | 13 | 62 |
| Total, serious adverse events | Febuxostat 40 mg | 0 | 61 |
| Total, serious adverse events | Febuxostat 80 mg | 0 | 51 |
| Total, serious adverse events | Overall RDEA3170 + Febuxostat Combination | 0 | 62 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT02246673
GET https://conductscience.org/api/trials/v1/NCT02246673/results?page=2