Trial · NCT00102440
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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. |
| Secondary | Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening. | Baseline and Week 28 | The 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 no longer palpable at the Week 28 visit, the total count was assumed to be zero. |
| Secondary | Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening. | Baseline and Week 52 | The change from baseline at Week 52 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 no longer palpable at the Week 52 visit, the total count was assumed to be zero. |
| Secondary | Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening. | Baseline and Final Visit (up to 52 weeks) | Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at 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 Gout Flares Between Weeks 8 and 52. | Weeks 8 through 52 | The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 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.govtrials-2026-11-12-0.5.0
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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GET https://conductscience.org/api/trials/v1/NCT00102440/registered