Clinical trial
Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic…
NCT00325195 · Savient Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT00325195 |
|---|---|
| Title | Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout |
| Official title | Randomized, Multicenter, Double-blind, Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout |
| Lead sponsor | Savient Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Gout |
| Intervention type | Biological, Other |
| Interventions | placebo, pegloticase |
| Enrollment | 225 |
| Start date | May 1, 2006 |
| Primary completion | Oct 1, 2007 |
| Completion | Dec 1, 2007 |
| First posted | May 12, 2006 |
| Last update posted | Feb 28, 2011 |
| Countries | Canada, Mexico, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: