Trial · NCT05007392
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
NCT05007392, Phase 3, Completed, Eisai Co., Ltd.; results first posted 2025-07-30
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout. Trials, record NCT05007392. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05007392
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
- NCT number
- NCT05007392
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 451 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Gout
- Interventions
- Dotinurad, Febuxostat, Dotinurad Matched Placebo, Febuxostat Matched Placebo
- First posted
- 2021-08-16
- Last updated
- 2025-07-30
- Results first posted
- 2025-07-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF) | At Week 24 | Percentage of participants with SUA level less than or equal to (\<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method. |
| Secondary | Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF) | At Week 12 | Percentage of participants with SUA level \<=6.0 mg/dL at Week 12 was reported. In case the SUA level was missing, this data was compensated by the LOCF method. |
| Secondary | Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 | At Weeks 4, 8, 12, 16, 20 and 24 | Percentage of participants with SUA level \<=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 was reported. Data was reported for observed participants at specified visits. |
| Secondary | Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Mean percent reduction from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported. |
| Secondary | Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Mean change from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported. |
| Secondary | Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Mean SUA level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 was reported. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF) | At Week 24 | Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF) | At Week 12 | Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 | At Weeks 4, 8, 12, 16, 20 and 24 | Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified timepoints. | percentage of participants | NUMBER |
| SECONDARY | Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified timepoints. | Percent change in SUA level | MEAN |
| SECONDARY | Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified timepoints. | mg/dL | MEAN |
| SECONDARY | Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number analyzed signifies those participants who were evaluable at specified timepoints. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF) | Febuxostat | 38.1 | 95% Confidence Interval 31.6 to 44.5 | percentage of participants | |
| Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF) | Dotinurad | 73.6 | 95% Confidence Interval 67.8 to 79.5 | percentage of participants | |
| Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF) | Febuxostat | 50.5 | 95% Confidence Interval 43.8 to 57.1 | percentage of participants | |
| Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF) | Dotinurad | 55.5 | 95% Confidence Interval 48.9 to 62.0 | percentage of participants | |
| Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 | Febuxostat | Week 4 | 26.3 | percentage of participants | |
| Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 | Dotinurad | Week 4 | 27.6 | percentage of participants | |
| Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 | Febuxostat | Week 8 | 55.6 | percentage of participants | |
| Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 | Dotinurad | Week 8 | 62.7 | percentage of participants | |
| Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 | Febuxostat | Wee 12 | 52.8 | percentage of participants | |
| Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 | Dotinurad | Wee 12 | 56.9 | percentage of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Febuxostat | 226 | |
| Overall Study | STARTED | Dotinurad | 225 | |
| Overall Study | Safety Analysis Set | Febuxostat | 225 | |
| Overall Study | Safety Analysis Set | Dotinurad | 223 | |
| Overall Study | Full Analysis Set | Febuxostat | 220 | |
| Overall Study | Full Analysis Set | Dotinurad | 221 | |
| Overall Study | COMPLETED | Febuxostat | 197 | |
| Overall Study | COMPLETED | Dotinurad | 195 | |
| Overall Study | NOT COMPLETED | Febuxostat | 29 | |
| Overall Study | NOT COMPLETED | Dotinurad | 30 |
Source ClinicalTrials.gov
Adverse events498
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 | Anaemia | Blood and lymphatic system disorders | Febuxostat | 2 | 225 | |
| other | Anaemia | Blood and lymphatic system disorders | Dotinurad | 2 | 223 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Febuxostat | 0 | 225 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Dotinurad | 1 | 223 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Febuxostat | 0 | 225 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Dotinurad | 1 | 223 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Febuxostat | 0 | 225 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Dotinurad | 1 | 223 | |
| other | Monocytopenia | Blood and lymphatic system disorders | Febuxostat | 0 | 225 | |
| other | Monocytopenia | Blood and lymphatic system disorders | Dotinurad | 1 | 223 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Febuxostat | 0 | 225 |
| Total, all-cause mortality | Dotinurad | 0 | 223 |
| Total, other adverse events | Febuxostat | 203 | 225 |
| Total, other adverse events | Dotinurad | 201 | 223 |
| Total, serious adverse events | Febuxostat | 4 | 225 |
| Total, serious adverse events | Dotinurad | 3 | 223 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Febuxostat vs Dotinurad: deaths from any cause | Trial comparisons |
| Febuxostat vs Dotinurad: 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/NCT05007392
GET https://conductscience.org/api/trials/v1/NCT05007392/results?page=2