Trial · NCT00430248
Efficacy and Safety of Oral Febuxostat in Participants With Gout
NCT00430248, Phase 3, Completed, Takeda; results first posted 2009-07-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Oral Febuxostat in Participants With Gout. Trials, record NCT00430248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00430248
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Oral Febuxostat in Participants With Gout
- NCT number
- NCT00430248
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,269 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gout
- Interventions
- Febuxostat, Febuxostat, Allopurinol
- First posted
- 2007-02-01
- Last updated
- 2012-02-02
- Results first posted
- 2009-07-16
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. | Last Visit on treatment (up to 6 months) | The percentage of subjects whose serum urate level was \<6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected. |
| Secondary | Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl | Last Visit on treatment (up to 6 months) | The percentage of subjects with mild-to-moderate renal impairment whose serum urate was \<6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. |
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. | Month 2 | Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 2 visit was summarized. |
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit. | Month 4 | Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 4 visit was summarized. |
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit. | Month 6 | Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 6 visit was summarized. |
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit. | Month 2 | Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 2 visit was summarized. |
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit. | Month 4 | Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 4 visit was summarized. |
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit. | Month 6 | Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 6 visit was summarized. |
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit. | Last Visit on treatment (up to 6 months) | The percentage of subjects whose serum urate level was \<5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected. |
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit | Month 2 | Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 2 visit was summarized. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. | Last Visit on treatment (up to 6 months) | Analysis was performed on intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. A subject's baseline value was used in the primary analysis if no postbaseline serum urate level was obtained. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl | Last Visit on treatment (up to 6 months) | Analysis was performed on the ITT subjects with mild-to-moderate renal impairment (estimated creatinine clearance of 30 mL/min to 89 mL/min), with a post-baseline serum urate level. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. | Month 2 | Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit. | Month 4 | Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit. | Month 6 | Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit. | Month 2 | Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit. | Month 4 | Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit. | Month 6 | Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit. | Last Visit on treatment (up to 6 months) | Analysis was performed on the ITT subjects with a post-baseline serum urate value. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit | Month 2 | Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit. | percentage of subjects | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. | Febuxostat 40 mg QD | 45.2 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. | Febuxostat 80 mg QD | 67.1 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. | Allopurinol 200 mg or 300 mg QD | 42.1 | percentage of subjects | ||
| Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl | Febuxostat 40 mg QD | 49.7 | percentage of subjects | ||
| Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl | Febuxostat 80 mg QD | 71.6 | percentage of subjects | ||
| Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl | Allopurinol 200 mg or 300 mg QD | 42.3 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. | Febuxostat 40 mg QD | 49.1 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. | Febuxostat 80 mg QD | 74.1 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. | Allopurinol 200 mg or 300 mg QD | 43.2 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit. | Febuxostat 40 mg QD | 47.1 | percentage of subjects |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Febuxostat 40 mg QD | 757 | |
| Overall Study | STARTED | Febuxostat 80 mg QD | 756 | |
| Overall Study | STARTED | Allopurinol 200 mg or 300 mg QD | 756 | |
| Overall Study | COMPLETED | Febuxostat 40 mg QD | 632 | |
| Overall Study | COMPLETED | Febuxostat 80 mg QD | 598 | |
| Overall Study | COMPLETED | Allopurinol 200 mg or 300 mg QD | 621 | |
| Overall Study | NOT COMPLETED | Febuxostat 40 mg QD | 125 | |
| Overall Study | NOT COMPLETED | Febuxostat 80 mg QD | 158 | |
| Overall Study | NOT COMPLETED | Allopurinol 200 mg or 300 mg QD | 135 |
Source ClinicalTrials.gov
Adverse events177
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 Infections | Infections and infestations | Febuxostat 40 mg QD | 71 | 757 | |
| other | Upper Respiratory Tract Infections | Infections and infestations | Febuxostat 80 mg QD | 53 | 756 | |
| other | Upper Respiratory Tract Infections | Infections and infestations | Allopurinol 200 mg or 300 mg QD | 57 | 756 | |
| other | Liver Function Analyses | Investigations | Febuxostat 40 mg QD | 63 | 757 | |
| other | Liver Function Analyses | Investigations | Febuxostat 80 mg QD | 52 | 756 | |
| other | Liver Function Analyses | Investigations | Allopurinol 200 mg or 300 mg QD | 50 | 756 | |
| other | Diarrhoea (Excluding Infective) | Gastrointestinal disorders | Febuxostat 40 mg QD | 45 | 757 | |
| other | Diarrhoea (Excluding Infective) | Gastrointestinal disorders | Febuxostat 80 mg QD | 47 | 756 | |
| other | Diarrhoea (Excluding Infective) | Gastrointestinal disorders | Allopurinol 200 mg or 300 mg QD | 57 | 756 | |
| other | Musculoskeletal and Connective Tissues Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | Febuxostat 40 mg QD | 43 | 757 |
1 to 10 of 177Source ClinicalTrials.gov
See all 177 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Febuxostat 40 mg QD | ||
| Total, all-cause mortality | Febuxostat 80 mg QD | ||
| Total, all-cause mortality | Allopurinol 200 mg or 300 mg QD | ||
| Total, other adverse events | Febuxostat 40 mg QD | 193 | |
| Total, other adverse events | Febuxostat 80 mg QD | 167 | |
| Total, other adverse events | Allopurinol 200 mg or 300 mg QD | 166 | |
| Total, serious adverse events | Febuxostat 40 mg QD | 19 | |
| Total, serious adverse events | Febuxostat 80 mg QD | 28 | |
| Total, serious adverse events | Allopurinol 200 mg or 300 mg QD | 31 |
Source ClinicalTrials.gov
Papers7
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.
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/NCT00430248
GET https://conductscience.org/api/trials/v1/NCT00430248/results?page=2