Trial · NCT02498652
Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
NCT02498652, Phase 2, Completed, Ardea Biosciences, Inc.; results first posted 2018-01-23
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects. Trials, record NCT02498652. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02498652
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
- NCT number
- NCT02498652
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Ardea Biosciences, Inc.
- Conditions
- Gout
- Interventions
- RDEA3170 2.5 mg, allopurinol 300 mg
- First posted
- 2015-07-15
- Last updated
- 2018-01-23
- Results first posted
- 2018-01-23
- Limitations and caveats
- Reliable urine uric acid values were not obtained due to sample processing errors, and this has resulted in the inability to assess the PD effects of RDEA3170 and/or allopurinol in urine.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1) |
| Primary | Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1) |
| Primary | Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1) |
| Primary | Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1) |
| Primary | Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2) |
| Primary | Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2) |
| Primary | Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2) |
| Primary | Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2) |
| Secondary | Maximum Observed Concentration (Cmax) | Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) | Cmax of Allopurinol alone or in combination with RDEA3170 |
| Secondary | Time of Occurrence of Maximum Observed Concentration (Tmax) | Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) | Tmax of Allopurinol alone or in combination with RDEA3170 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Maximum Percentage (%) Change | MEAN | |
| PRIMARY | Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | mg/dL | MEAN | |
| PRIMARY | Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Percentage (%) Change | MEAN | |
| PRIMARY | Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Percentage (%) Change | MEAN | |
| PRIMARY | Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) | Maximum Percentage (%) Change | MEAN | |
| SECONDARY | Maximum Observed Concentration (Cmax) | Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) | µg/mL | GEOMETRIC_MEAN | |
| SECONDARY | Time of Occurrence of Maximum Observed Concentration (Tmax) | Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) | hr | GEOMETRIC_MEAN | |
| SECONDARY | Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) | Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) | µg·hr/mL | GEOMETRIC_MEAN | |
| SECONDARY | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) | Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) | µg·hr/mL | GEOMETRIC_MEAN | |
| SECONDARY | Apparent Terminal Half-life (t1/2) | Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) | hr | GEOMETRIC_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group95
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Treatment A1 | -40.2 | Standard Error 3.29 | Maximum Percentage (%) Change | |
| Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Treatment A2q | -55.0 | Standard Error 4.96 | Maximum Percentage (%) Change | |
| Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Treatment A2b | -56.8 | Standard Error 4.52 | Maximum Percentage (%) Change | |
| Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Treatment R1 | -48.1 | Standard Error 2.91 | Maximum Percentage (%) Change | |
| Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Treatment R3 | -61.0 | Standard Error 2.59 | Maximum Percentage (%) Change | |
| Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) | Treatment R5 | -69.5 | Standard Error 2.09 | Maximum Percentage (%) Change | |
| Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. | Treatment A1 | 5.8 | Standard Error 0.24 | mg/dL | |
| Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. | Treatment A2q | 4.8 | Standard Error 0.38 | mg/dL | |
| Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. | Treatment A2b | 4.0 | Standard Error 0.39 | mg/dL | |
| Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. | Treatment R1 | 5.5 | Standard Error 0.24 | mg/dL |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 20 | |
| Overall Study | STARTED | Cohort 2 | 21 | |
| Overall Study | COMPLETED | Cohort 1 | 20 | |
| Overall Study | COMPLETED | Cohort 2 | 20 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 1 |
Source ClinicalTrials.gov
Adverse events30
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 | Upper Respiratory Tract Infection | Infections and infestations | Cohort 1 | 2 | 20 | 2 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Cohort 2 | 2 | 21 | 2 |
| other | Headache | Nervous system disorders | Cohort 1 | 0 | 20 | 0 |
| other | Headache | Nervous system disorders | Cohort 2 | 3 | 21 | 3 |
| other | Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Cohort 1 | 0 | 20 | 0 |
| other | Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Cohort 2 | 2 | 21 | 2 |
| other | Sinusitis | Infections and infestations | Cohort 1 | 1 | 20 | 1 |
| other | Sinusitis | Infections and infestations | Cohort 2 | 0 | 21 | 0 |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Cohort 1 | 0 | 20 | 0 |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Cohort 2 | 1 | 21 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 20 |
| Total, all-cause mortality | Cohort 2 | 0 | 21 |
| Total, other adverse events | Cohort 1 | 6 | 20 |
| Total, other adverse events | Cohort 2 | 6 | 21 |
| Total, serious adverse events | Cohort 1 | 1 | 20 |
| Total, serious adverse events | Cohort 2 | 0 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29531784 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: 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.
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/NCT02498652
GET https://conductscience.org/api/trials/v1/NCT02498652/results?page=2