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| Sponsor: | BioCryst Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | BioCryst Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01407874 |
Purpose
To evaluate the overall safety and tolerability of BCX4208 when combined with allopurinol in subjects with moderate renal insufficiency.
| Condition | Intervention | Phase |
|---|---|---|
|
Gout Hyperuricemia Arthritis Joint Disease Renal Insufficiency |
Drug: BCX4208 Drug: Allopurinol 200mg |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral BCX4208 Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency |
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BCX4208 Placebo
BCX4208 Placebo + Allopurinol 200mg
|
Drug: BCX4208
Oral dose administered daily for 84 days.
Drug: Allopurinol 200mg
Oral dose administered daily for 84 days
|
|
Experimental: BCX4208 5mg
BCX4208 5mg + Allopurinol 200 mg
|
Drug: BCX4208
Oral dose administered daily for 84 days.
Drug: Allopurinol 200mg
Oral dose administered daily for 84 days
|
|
Experimental: BCX4208 10mg
BCX4208 10mg + Allopurinol 200mg
|
Drug: BCX4208
Oral dose administered daily for 84 days.
Drug: Allopurinol 200mg
Oral dose administered daily for 84 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Peoria, Arizona, United States, 85381 | |
| United States, California | |
| Irvine, California, United States, 92618 | |
| United States, Florida | |
| Oldsmar, Florida, United States, 34677 | |
| United States, Hawaii | |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Kansas | |
| Newton, Kansas, United States, 67114 | |
| United States, Tennessee | |
| Knoxville, Tennessee, United States, 37923 | |
| United States, Texas | |
| Dallas, Texas, United States, 75235 | |
| San Antonio, Texas, United States, 78215 | |
| United States, Virginia | |
| Alexandria, Virginia, United States, 22304 | |
| Study Director: | Alan Hollister, MD, PhD | BioCryst Pharmaceuticals |
More Information
| Responsible Party: | BioCryst Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01407874 History of Changes |
| Other Study ID Numbers: | BCX4208-204 |
| Study First Received: | August 1, 2011 |
| Last Updated: | May 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Gout Hyperuricemia Arthritis |
Joint Disease Allopurinol Renal Insufficiency |
|
Arthritis Gout Joint Diseases Hyperuricemia Renal Insufficiency Musculoskeletal Diseases Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Pathologic Processes Kidney Diseases Urologic Diseases |
Allopurinol Uric Acid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs |