Trial · NCT00174915
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
NCT00174915, Phase 3, Completed, Takeda; results first posted 2009-07-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects. Trials, record NCT00174915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00174915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
- NCT number
- NCT00174915
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,072 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gout
- Interventions
- Febuxostat, Febuxostat, Febuxostat, Allopurinol, Placebo
- First posted
- 2005-09-15
- Last updated
- 2012-02-02
- Results first posted
- 2009-07-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). | Last 3 visits (any last 3 visits up to week 28) | 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 Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 | 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 Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit | Final Visit (up to 28 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 and may have differed by 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 Final Visit | Baseline and Final Visit (up to 28 weeks) | The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as \[(Final visit - baseline levels)/baseline\]\*100. 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 in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. | 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 in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. | Baseline and Final Visit (up to 28 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. |
| Secondary | Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit. | Baseline and Week 28 | Change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were not palpable at the Week 28 visit, the total count was assumed to be 0. |
| Secondary | Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit | Final Visit (up to 28 weeks) | Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject. |
| Secondary | Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period. | Weeks 8 through 28 | Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once. |
Source ClinicalTrials.gov
Outcomes10
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 Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). | Last 3 visits (any last 3 visits up to week 28) | Analysis was performed on all randomized subjects who took at least 1 dose of study drug and had a baseline serum urate ≥8.0 mg/dL. If subject prematurely discontinued from study before at least 3 serum urate levels were obtained, subject was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 | Week 28 | Analysis was performed on intend 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. Missing data were not imputed. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit | Final Visit (up to 28 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 | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Urate Levels at Final Visit | Baseline and Final Visit (up to 28 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 | MEAN |
| SECONDARY | Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. | 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, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed. | percent change from baseline | MEDIAN |
| SECONDARY | Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. | Baseline and Final Visit (up to 28 weeks) | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed. | percent change from baseline | MEDIAN |
| SECONDARY | Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit. | 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 palpable tophi at the screening visit. Missing data were not imputed. | number of tophi | MEDIAN |
| SECONDARY | Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit | Final Visit (up to 28 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 palpable tophi at the screening visit. Missing data were not imputed. | number of tophi | MEDIAN |
| SECONDARY | Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period. | Weeks 8 through 28 | Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 28. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group50
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 Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). | Febuxostat 80 mg QD | 48 | Percentage of subjects | ||
| Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). | Febuxostat 120 mg QD | 65 | Percentage of subjects | ||
| Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). | Febuxostat 240 mg QD | 69 | Percentage of subjects | ||
| Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). | Allopurinol QD | 22 | Percentage of subjects | ||
| Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). | Placebo QD | 0 | Percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 | Febuxostat 80 mg QD | 76 | Percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 | Febuxostat 120 mg QD | 87 | Percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 | Febuxostat 240 mg QD | 94 | Percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 | Allopurinol QD | 41 | Percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 | Placebo QD | 1 | Percentage of subjects |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Febuxostat 80 mg QD | 267 | |
| Overall Study | STARTED | Febuxostat 120 mg QD | 269 | |
| Overall Study | STARTED | Febuxostat 240 mg QD | 134 | |
| Overall Study | STARTED | Allopurinol QD | 268 | |
| Overall Study | STARTED | Placebo QD | 134 | |
| Overall Study | COMPLETED | Febuxostat 80 mg QD | 174 | |
| Overall Study | COMPLETED | Febuxostat 120 mg QD | 200 | |
| Overall Study | COMPLETED | Febuxostat 240 mg QD | 86 | |
| Overall Study | COMPLETED | Allopurinol QD | 211 | |
| Overall Study | COMPLETED | Placebo QD | 101 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events215
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 (Excluding Infective) | Gastrointestinal disorders | Febuxostat 80 mg QD | 16 | 267 | |
| other | Diarrhoea (Excluding Infective) | Gastrointestinal disorders | Febuxostat 120 mg QD | 19 | 269 | |
| other | Diarrhoea (Excluding Infective) | Gastrointestinal disorders | Febuxostat 240 mg QD | 18 | 134 | |
| other | Diarrhoea (Excluding Infective) | Gastrointestinal disorders | Allopurinol QD | 17 | 268 | |
| other | Diarrhoea (Excluding Infective) | Gastrointestinal disorders | Placebo QD | 11 | 134 | |
| other | Gastrointestinal & Abdominal Pains, Excluding Oral,Throat | Gastrointestinal disorders | Febuxostat 80 mg QD | 5 | 267 | |
| other | Gastrointestinal & Abdominal Pains, Excluding Oral,Throat | Gastrointestinal disorders | Febuxostat 120 mg QD | 7 | 269 | |
| other | Gastrointestinal & Abdominal Pains, Excluding Oral,Throat | Gastrointestinal disorders | Febuxostat 240 mg QD | 8 | 134 | |
| other | Gastrointestinal & Abdominal Pains, Excluding Oral,Throat | Gastrointestinal disorders | Allopurinol QD | 6 | 268 | |
| other | Gastrointestinal & Abdominal Pains, Excluding Oral,Throat | Gastrointestinal disorders | Placebo QD | 3 | 134 |
1 to 10 of 215Source ClinicalTrials.gov
See all 215 adverse eventsAdverse event totals15
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 | Febuxostat 240 mg QD | ||
| Total, all-cause mortality | Allopurinol QD | ||
| Total, all-cause mortality | Placebo QD | ||
| Total, other adverse events | Febuxostat 80 mg QD | 122 | 267 |
| Total, other adverse events | Febuxostat 120 mg QD | 123 | 269 |
| Total, other adverse events | Febuxostat 240 mg QD | 72 | 134 |
| Total, other adverse events | Allopurinol QD | 133 | 268 |
| Total, other adverse events | Placebo QD | 61 | 134 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
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/NCT00174915
GET https://conductscience.org/api/trials/v1/NCT00174915/results?page=2