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| Sponsor: | BioCryst Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | BioCryst Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00985127 |
Purpose
The study will be conducted in two parts. The first is a parallel-group design, evaluating doses of 40 mg, 80 mg or 120 mg BCX-4208. The second part is planned as a dose-escalation study, evaluating higher doses including 160 mg, 240 mg and 320 mg BCX-4208. The study's primary endpoint is the change in uric acid in the blood compared to baseline measurement prior to treatment, assessed on Day 22.
| Condition | Intervention | Phase |
|---|---|---|
|
Gout |
Drug: placebo Drug: BCX4208 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Dose-Ranging, Two-Part, Multi-Center Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout |
| Enrollment: | 99 |
| Study Start Date: | September 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 40 mg
40 mg BCX4208
|
Drug: BCX4208
Administered daily for 21 days.
|
|
Experimental: 80 mg
BCX4208
|
Drug: BCX4208
Administered daily for 21 days.
|
|
Experimental: 120 mg
BCX4208
|
Drug: BCX4208
Administered daily for 21 days.
|
| Placebo Comparator: sugar pill |
Drug: placebo
administered daily for 21 days
|
|
Experimental: 160mg
BCX4208
|
Drug: BCX4208
Administered daily for 21 days.
|
|
Experimental: 240mg
BCX4208
|
Drug: BCX4208
Administered daily for 21 days.
|
|
Experimental: 320mg
BCX4208
|
Drug: BCX4208
Administered daily for 21 days.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female participants must meet at least one of the following specifications:
Exclusion Criteria:
Contacts and Locations
Show 24 Study Locations
More Information
| Responsible Party: | BioCryst Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00985127 History of Changes |
| Other Study ID Numbers: | BCX4208-201 |
| Study First Received: | September 25, 2009 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Hyperuricemia Gout |
|
Gout Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases |