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A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout

NCT02287818 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2022-06-28

Study results available
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Summary

The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.

Conditions

Interventions

DRUG

Placebo

Placebo twice daily from Day 1 to Week 12

DRUG

AC-201

AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12

DRUG

Febuxostat

Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL

Sponsors & Collaborators

  • TWi Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Chang-Youh Tsai · Taipei Veteran General Hospital (TVGH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-10-27
Completion
2016-10-27

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02287818 on ClinicalTrials.gov