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Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients

NCT01416402 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-04-03

No results posted yet for this study

Summary

The purpose of this study is to determine whether arhalofenate is safe and effective when dosed in combination with febuxostat in lowering serum uric acid in patients with gout.

Conditions

  • Hyperuricemia
  • Gout

Interventions

DRUG

Arhalofenate

400 mg once daily orally for two weeks then up-titrated to 600 mg once daily orally for an additional two weeks

DRUG

Febuxostat

80 mg once daily orally for 5 weeks

DRUG

Colchicine

Colchicine 0.6 mg daily as prophylaxis to prevent gout flares

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416402 on ClinicalTrials.gov