Trial · NCT00175019
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
NCT00175019, Phase 3, Completed, Takeda; results first posted 2009-09-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010. Trials, record NCT00175019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00175019
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
- NCT number
- NCT00175019
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,086 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gout
- Interventions
- Febuxostat, Febuxostat, Allopurinol
- First posted
- 2005-09-15
- Last updated
- 2010-07-27
- Results first posted
- 2009-09-07
- Limitations and caveats
Subjects may receive \>1 treatment. Adverse events are summarized by treatment at time of observation and subjects who receive \>1 treatment are summarized for each treatment they receive, so subjects at risk will not match number of participants.
Source ClinicalTrials.gov
Registered outcomes13
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 Decreases to < 6.0 mg/dL at Month 1. | Month 1 | Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 1 visit was summarized. |
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12. | Month 12 | Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 12 visit was summarized. |
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24. | Month 24 | Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 24 visit was summarized. |
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36. | Month 36 | Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 36 visit was summarized. |
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment. | Last Visit on treatment (up to 40 months). | The percentage of subjects whose serum urate was \<6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment. |
| Secondary | Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment. | Last Visit on treatment (up to 40 months). | The percent change in serum urate from baseline to the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment. |
| Secondary | Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline. | Month 12 | The area of the primary tophus was calculated based on the length and width of the tophus measured at the Month 12 visit. The percent change from baseline in primary tophus size to the Month 12 visit was summarized. |
| Secondary | Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline. | Month 24 | The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 24 visit. The percent change from baseline in primary tophus size to the Month 24 visit was summarized. |
| Secondary | Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline. | Month 36 | The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 36 visit. The percent change from baseline in primary tophus size to the Month 36 visit was summarized. |
| Secondary | Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline. | Final Visit (up to 40 months). | The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and final visit. The percent change from baseline in primary tophus size to the final visit was summarized. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment. | Last Visit on treatment (up to 40 months). | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis. | percent change from baseline | MEAN |
| SECONDARY | Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline. | Month 12 | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 12 visit were included in the analysis. | percent change from baseline | MEDIAN |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. | Month 1 | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 1 visit and who had not changed from their initial treatment were included in the analysis. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12. | Month 12 | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 12 visit and who had not changed from their initial treatment were included in the analysis. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24. | Month 24 | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 24 visit and who had not changed from their initial treatment were included in the analysis. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36. | Month 36 | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 36 visit and who had not changed from their initial treatment were included in the analysis. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment. | Last Visit on treatment (up to 40 months). | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis. | percentage of subjects | NUMBER |
| SECONDARY | Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline. | Month 24 | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 24 visit were included in the analysis. | percent change from baseline | MEDIAN |
| SECONDARY | Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline. | Month 36 | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 36 visit were included in the analysis. | percent change from baseline | MEDIAN |
| SECONDARY | Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline. | Final Visit (up to 40 months). | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured while receiving their final stable treatment were included in the analysis. | percent change from baseline | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment. | Febuxostat 80 mg QD | -46.69 | Standard Deviation 17.43 | percent change from baseline | |
| Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment. | Febuxostat 120 mg QD | -52.99 | Standard Deviation 19.12 | percent change from baseline | |
| Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment. | Allopurinol QD | -32.17 | Standard Deviation 17.71 | percent change from baseline | |
| Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline. | Febuxostat 80 mg QD | -82 | Inter-Quartile Range -100 to -40 | percent change from baseline | |
| Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline. | Febuxostat 120 mg QD | -79 | Inter-Quartile Range -100 to -26 | percent change from baseline | |
| Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline. | Allopurinol QD | -56 | Inter-Quartile Range -100 to -16 | percent change from baseline | |
| Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. | Febuxostat 80 mg QD | 80.8 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. | Febuxostat 120 mg QD | 87.0 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. | Allopurinol QD | 46.0 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12. | Febuxostat 80 mg QD | 88.9 | percentage of subjects |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 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 | 606 | |
| Overall Study | STARTED | Febuxostat 120 mg QD | 388 | |
| Overall Study | STARTED | Allopurinol QD | 92 | |
| Overall Study | COMPLETED | Febuxostat 80 mg QD | 412 | |
| Overall Study | COMPLETED | Febuxostat 120 mg QD | 217 | |
| Overall Study | COMPLETED | Allopurinol QD | 35 | |
| Overall Study | NOT COMPLETED | Febuxostat 80 mg QD | 194 | |
| Overall Study | NOT COMPLETED | Febuxostat 120 mg QD | 171 | |
| Overall Study | NOT COMPLETED | Allopurinol QD | 57 |
Source ClinicalTrials.gov
Adverse events315
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 | 38 | 801 | |
| other | Diarrhoea (Excl Infective) | Gastrointestinal disorders | Febuxostat 120 mg QD | 33 | 487 | |
| other | Diarrhoea (Excl Infective) | Gastrointestinal disorders | Allopurinol QD | 4 | 178 | |
| other | Oedema NEC | General disorders | Febuxostat 80 mg QD | 49 | 801 | |
| other | Oedema NEC | General disorders | Febuxostat 120 mg QD | 17 | 487 | |
| other | Oedema NEC | General disorders | Allopurinol QD | 3 | 178 | |
| other | Influenza Viral Infections | Infections and infestations | Febuxostat 80 mg QD | 44 | 801 | |
| other | Influenza Viral Infections | Infections and infestations | Febuxostat 120 mg QD | 16 | 487 | |
| other | Influenza Viral Infections | Infections and infestations | Allopurinol QD | 2 | 178 | |
| other | Lower Respiratory Tract and Lung Infections | Infections and infestations | Febuxostat 80 mg QD | 60 | 801 |
1 to 10 of 315Source ClinicalTrials.gov
See all 315 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 QD | ||
| Total, other adverse events | Febuxostat 80 mg QD | 444 | 801 |
| Total, other adverse events | Febuxostat 120 mg QD | 257 | 487 |
| Total, other adverse events | Allopurinol QD | 66 | 178 |
| Total, serious adverse events | Febuxostat 80 mg QD | 98 | 801 |
| Total, serious adverse events | Febuxostat 120 mg QD | 50 | 487 |
| Total, serious adverse events | Allopurinol QD | 16 | 178 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19286847 | RESULT |
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 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
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