Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
This study has been completed.
Sponsor:
Nuon Therapeutics, Inc.
Information provided by:
Nuon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00995618
First received: October 6, 2009
Last updated: January 5, 2011
Last verified: January 2011
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Purpose
This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.
| Condition | Intervention | Phase |
|---|---|---|
|
Gout Hyperuricemia |
Drug: Tranilast Drug: Febuxostat Drug: Combination - Tranilast and Febuxostat |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Healthy Subjects With Hyperuricemia |
Resource links provided by NLM:
Further study details as provided by Nuon Therapeutics, Inc.:
Primary Outcome Measures:
- Mean decrease in serum uric acid levels [ Time Frame: Seven days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination [ Time Frame: 7 days ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | September 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tranilast
Tranilast tablets
|
Drug: Tranilast
Tranilast tablets, 300 mg, QD
|
|
Active Comparator: Febuxostat
Febuxostat tablets
|
Drug: Febuxostat
Febuxostat Tablets, 40 mg, QD
Other Name: Uloric
|
|
Experimental: Combination
Tranilast plus febuxostat
|
Drug: Combination - Tranilast and Febuxostat
Tranilast, 300 mg QD; Febuxostat, 40 mg QD
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female, aged 18 to 70
- Subjects with hyperuricemia who are otherwise healthy
Exclusion Criteria:
- Pregnant or nursing
- Known history of gout
- Clinically significant infection at Screening
- Known sensitivity to tranilast or febuxostat
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995618
Locations
| United States, Hawaii | |
| Nuon Investigative Site | |
| Honolulu, Hawaii, United States | |
| United States, Indiana | |
| Nuon Investigative Site | |
| Evansville, Indiana, United States | |
| United States, Texas | |
| Nuon Investigative Site | |
| Dallas, Texas, United States | |
Sponsors and Collaborators
Nuon Therapeutics, Inc.
Investigators
| Study Director: | Director, Nuon Clinical Trials Group | Nuon Therapeutics, Inc. |
More Information
No publications provided
| Responsible Party: | Nuon Therapeutics Clinical Trials Contact, Nuon Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00995618 History of Changes |
| Other Study ID Numbers: | A3006GT |
| Study First Received: | October 6, 2009 |
| Last Updated: | January 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Nuon Therapeutics, Inc.:
|
Gout Hyperuricemia |
Additional relevant MeSH terms:
|
Gout Hyperuricemia Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Pathologic Processes Tranilast Febuxostat Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents |
ClinicalTrials.gov processed this record on May 16, 2013