Trial · NCT00174941
Long-Term Safety of Febuxostat in Subjects With Gout.
NCT00174941, Phase 2, Completed, Takeda; results first posted 2009-07-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Safety of Febuxostat in Subjects With Gout. Trials, record NCT00174941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00174941
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety of Febuxostat in Subjects With Gout.
- NCT number
- NCT00174941
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 116 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gout
- Interventions
- Febuxostat, Febuxostat, Febuxostat
- First posted
- 2005-09-15
- Last updated
- 2011-01-27
- Results first posted
- 2009-07-16
Source ClinicalTrials.gov
Registered outcomes16
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 or is Maintained at <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. |
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | 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 or is Maintained at <6.0 mg/dL at Month 18 Visit. | Month 18 | Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 18 visit was summarized. |
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. | 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 or is Maintained at <6.0 mg/dL at Month 36 Visit. | 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 or is Maintained at <6.0 mg/dL at Month 48 Visit. | Month 48 | Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 48 visit was summarized. |
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. | Month 60 | Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 60 visit was summarized. |
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. | Last Visit on treatment (up to 66 months). | 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. |
| Secondary | Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | Baseline and Month 6 | Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized. |
| Secondary | Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. | Baseline and Month 12 | Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | Month 6 | Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percentage of subjects | NUMBER |
| SECONDARY | Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | Baseline and Month 6 | Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percent change from baseline | MEAN |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | Month 12 | Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. | Month 18 | Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. | Month 24 | Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. | Month 36 | Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. | Month 48 | Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. | Month 60 | Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. | Last Visit on treatment (up to 66 months). | Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percentage of subjects | NUMBER |
| SECONDARY | Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. | Baseline and Month 12 | Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | percentage of subjects | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group64
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 Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | Febuxostat 40 mg QD | 50 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | Febuxostat 80 mg QD | 93 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | Febuxostat 120 mg QD | 65 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | Total Febuxostat | 82 | percentage of subjects | ||
| Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | Febuxostat 40 mg QD | -35.9 | Standard Deviation 9.55 | percent change from baseline | |
| Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | Febuxostat 80 mg QD | -50.6 | Standard Deviation 9.84 | percent change from baseline | |
| Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | Febuxostat 120 mg QD | -47.6 | Standard Deviation 19.6 | percent change from baseline | |
| Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | Total Febuxostat | -48.3 | Standard Deviation 13.07 | percent change from baseline | |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | Febuxostat 40 mg QD | 57 | percentage of subjects | ||
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | Febuxostat 80 mg QD | 85 | percentage of subjects |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Febuxostat 40 mg QD | 8 | |
| Overall Study | STARTED | Febuxostat 80 mg QD | 79 | |
| Overall Study | STARTED | Febuxostat 120 mg QD | 29 | |
| Overall Study | STARTED | Total Febuxostat | 116 | |
| Overall Study | COMPLETED | Febuxostat 40 mg QD | 6 | |
| Overall Study | COMPLETED | Febuxostat 80 mg QD | 41 | |
| Overall Study | COMPLETED | Febuxostat 120 mg QD | 11 | |
| Overall Study | COMPLETED | Total Febuxostat | 58 | |
| Overall Study | NOT COMPLETED | Febuxostat 40 mg QD | 2 | |
| Overall Study | NOT COMPLETED | Febuxostat 80 mg QD | 38 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events192
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 | Gastrointestinal disorders | Febuxostat 40 mg QD | 0 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Febuxostat 80 mg QD | 9 | 116 | |
| other | Diarrhoea | Gastrointestinal disorders | Febuxostat 120 mg QD | 1 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | Febuxostat Total | 10 | 116 | |
| other | Liver Function Analyses | Investigations | Febuxostat 40 mg QD | 0 | 12 | |
| other | Liver Function Analyses | Investigations | Febuxostat 80 mg QD | 4 | 116 | |
| other | Liver Function Analyses | Investigations | Febuxostat 120 mg QD | 2 | 37 | |
| other | Liver Function Analyses | Investigations | Febuxostat Total | 6 | 116 | |
| other | Gastrointestinal Atonic and Hypomotility Disorders NEC | Gastrointestinal disorders | Febuxostat 40 mg QD | 0 | 12 | |
| other | Gastrointestinal Atonic and Hypomotility Disorders NEC | Gastrointestinal disorders | Febuxostat 80 mg QD | 5 | 116 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals12
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 | Febuxostat 120 mg QD | ||
| Total, all-cause mortality | Febuxostat Total | ||
| Total, other adverse events | Febuxostat 40 mg QD | 5 | 12 |
| Total, other adverse events | Febuxostat 80 mg QD | 44 | 116 |
| Total, other adverse events | Febuxostat 120 mg QD | 9 | 37 |
| Total, other adverse events | Febuxostat Total | 53 | 116 |
| Total, serious adverse events | Febuxostat 40 mg QD | 3 | 12 |
| Total, serious adverse events | Febuxostat 80 mg QD | 14 | 116 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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/NCT00174941
GET https://conductscience.org/api/trials/v1/NCT00174941/results?page=2