Trial · NCT00102440
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
NCT00102440, Phase 3, Completed, Takeda; results first posted 2009-07-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Febuxostat Versus Allopurinol Control Trial in Subjects With Gout. Trials, record NCT00102440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00102440
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
- NCT number
- NCT00102440
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 760 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gout
- Interventions
- Febuxostat, Febuxostat, Allopurinol
- First posted
- 2005-01-31
- Last updated
- 2012-02-02
- Results first posted
- 2009-07-16
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) | Last 3 Visits (up to 52 weeks) | Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject. |
| Secondary | Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit | Week 28 | Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Week 28 visit was summarized. |
| Secondary | Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit | Week 52 | Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Week 52 visit was summarized. |
| Secondary | Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit | Final Visit (up to 52 weeks) | The percentage of subjects 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. The timing of the final visit may have differed for each subject. |
| Secondary | Percent Change From Baseline in Serum Urate Levels at Week 28. | Baseline and Week 28 | Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as \[(week 28 - baseline levels/baseline)\]\*100 and summarized. |
| Secondary | Percent Change From Baseline in Serum Urate Levels at Week 52. | Baseline and Week 52 | Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as \[(week 52 - baseline levels/baseline)\]\*100 and summarized. |
| Secondary | Percent Change From Baseline in Serum Urate Levels at Final Visit | Baseline and Final Visit (up to 52 weeks) | The percent change in serum urate from baseline to the Final visit was calculated as \[(Final Visit - baseline levels/baseline)\]\*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject. |
| Secondary | Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | Baseline and Week 28 | The percent change from baseline in primary tophus size as determined by physical measurement was calculated as \[(Week 28 - baseline sizes)/baseline\]\*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero. |
| Secondary | Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | Baseline and Week 52 | The percent change from baseline in primary tophus size as determined by physical measurement was calculated as \[(Week 52 - baseline sizes)/baseline\]\*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero. |
| Secondary | Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | Baseline and Final Visit (up to 52 weeks) | Percent change in primary tophus size was calculated as \[(Final Visit - baseline sizes)/baseline\]\*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject. |
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 | Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) | Last 3 Visits (up to 52 weeks) | Analysis was performed on the intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit | Week 28 | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit | Week 52 | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit | Final Visit (up to 52 weeks) | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Percentage of subjects | NUMBER |
| SECONDARY | Percent Change From Baseline in Serum Urate Levels at Week 28. | Baseline and Week 28 | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | percent change from baseline | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Urate Levels at Week 52. | Baseline and Week 52 | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | percent change from baseline | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Urate Levels at Final Visit | Baseline and Final Visit (up to 52 weeks) | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | percent change from baseline | MEAN |
| SECONDARY | Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | Baseline and Week 28 | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed. | percent change from baseline | MEDIAN |
| SECONDARY | Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | Baseline and Week 52 | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed. | percent change from baseline | MEDIAN |
| SECONDARY | Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | Baseline and Final Visit (up to 52 weeks) | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed. | percent change from baseline | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) | Febuxostat 80 mg QD | 53 | Percentage of subjects | ||
| Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) | Febuxostat 120 mg QD | 62 | Percentage of subjects | ||
| Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) | Allopurinol 300 mg QD | 21 | Percentage of subjects | ||
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit | Febuxostat 80 mg QD | 72 | Percentage of subjects | ||
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit | Febuxostat 120 mg QD | 82 | Percentage of subjects | ||
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit | Allopurinol 300 mg QD | 42 | Percentage of subjects | ||
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit | Febuxostat 80 mg QD | 81 | Percentage of subjects | ||
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit | Febuxostat 120 mg QD | 82 | Percentage of subjects | ||
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit | Allopurinol 300 mg QD | 39 | Percentage of subjects | ||
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit | Febuxostat 80 mg QD | 74 | Percentage of subjects |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 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 80 mg QD | 256 | |
| Overall Study | STARTED | Febuxostat 120 mg QD | 251 | |
| Overall Study | STARTED | Allopurinol 300 mg QD | 253 | |
| Overall Study | COMPLETED | Febuxostat 80 mg QD | 168 | |
| Overall Study | COMPLETED | Febuxostat 120 mg QD | 153 | |
| Overall Study | COMPLETED | Allopurinol 300 mg QD | 187 | |
| Overall Study | NOT COMPLETED | Febuxostat 80 mg QD | 88 | |
| Overall Study | NOT COMPLETED | Febuxostat 120 mg QD | 98 | |
| Overall Study | NOT COMPLETED | Allopurinol 300 mg QD | 66 |
Source ClinicalTrials.gov
Adverse events183
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 | Diarrhoea (Excl Infective) | Gastrointestinal disorders | Febuxostat 80 mg QD | 27 | 256 | |
| other | Diarrhoea (Excl Infective) | Gastrointestinal disorders | Febuxostat 120 mg QD | 25 | 251 | |
| other | Diarrhoea (Excl Infective) | Gastrointestinal disorders | Allopurinol 300 mg QD | 16 | 253 | |
| other | Nausea and Vomiting Symptoms | Gastrointestinal disorders | Febuxostat 80 mg QD | 19 | 256 | |
| other | Nausea and Vomiting Symptoms | Gastrointestinal disorders | Febuxostat 120 mg QD | 13 | 251 | |
| other | Nausea and Vomiting Symptoms | Gastrointestinal disorders | Allopurinol 300 mg QD | 8 | 253 | |
| other | Oedema NEC | General disorders | Febuxostat 80 mg QD | 18 | 256 | |
| other | Oedema NEC | General disorders | Febuxostat 120 mg QD | 8 | 251 | |
| other | Oedema NEC | General disorders | Allopurinol 300 mg QD | 8 | 253 | |
| other | Influenza Viral Infections | Infections and infestations | Febuxostat 80 mg QD | 12 | 256 |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Febuxostat 80 mg QD | ||
| Total, all-cause mortality | Febuxostat 120 mg QD | ||
| Total, all-cause mortality | Allopurinol 300 mg QD | ||
| Total, other adverse events | Febuxostat 80 mg QD | 164 | 256 |
| Total, other adverse events | Febuxostat 120 mg QD | 145 | 251 |
| Total, other adverse events | Allopurinol 300 mg QD | 167 | 253 |
| Total, serious adverse events | Febuxostat 80 mg QD | 10 | 256 |
| Total, serious adverse events | Febuxostat 120 mg QD | 19 | 251 |
| Total, serious adverse events | Allopurinol 300 mg QD | 18 | 253 |
Source ClinicalTrials.gov
Papers4
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/NCT00102440
GET https://conductscience.org/api/trials/v1/NCT00102440/results?page=2