A Phase 2 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of MBX-102 in the Treatment of Hyperuricemia in Patients With Gout

CymaBay Therapeutics, Inc.0 sites67 target enrollmentMay 2011

ConditionsHyperuricemia Gout

InterventionsArhalofenate Colchicine Placebo comparator

DrugsArhalofenate Placebo comparator Colchicine

Overview

Phase: Phase 2
Intervention: Arhalofenate
Conditions: Hyperuricemia
Sponsor: CymaBay Therapeutics, Inc.
Enrollment: 67
Primary Endpoint: Serum uric acid
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in patients with gout.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

November 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CymaBay Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Read and sign the informed consent after the elements of consent have been fully explained and all questions have been addressed, prior to any study procedures.
•Known gout patient (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout in Appendix 3)
•the sUA must be ≥ 8.0 mg/dL and ≤12 mg/dL
•if on ULT, the patients must agree to temporarily discontinue their existing ULT and the sUA must be ≥ 8.0 mg/dL and ≤12 mg/dL after wash-out at Week -1
•Male or female, 18-75 years of age at Screening Visit
•All female patients must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or have a partner who has undergone vasectomy or must agree to use two medically accepted methods of contraception including a barrier method (see the list in Appendix 4) for the entire duration of the study unless reporting complete sexual abstinence.
•Female patients must not be pregnant or lactating
•Male patients with a female partner of child-bearing potential must agree to use condom or the partner must use a medically acceptable method of contraception for the entire duration of the study.
•Patients must have an estimated CrCl ≥ 60 mL/min as calculated by the Cockcroft-Gault method
•Serum creatinine value must be ≤ 1.1 mg/dL in females and ≤ 1.3 mg/dL in males

Exclusion Criteria

•Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant).
•Known patient with xanthinuria
•History of documented or suspected kidney stones
•Over producers of uric acid as evidenced by 24-hour urinary uric acid \> 800 mg (on normal unrestricted diet)
•Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
•History of illicit drug or alcohol abuse within last 1 year
•History of significant pulmonary disease, upper GI bleeding, documented peptic ulcer disease (unless known H. pylori infection treated successfully without recurrence), or nephrotic syndrome within last 3 years
•All patients must not have had a stroke, TIA, acute myocardial infarction, congestive heart failure (NYHA Class II-IV), angina pectoris, coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization), lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy within last 5 years
•Malignancy within the last 5 years (except resected basal cell carcinoma)
•Body mass index (BMI) \> 42 kg/m2