Clinical Trials Listing Service

Gout

Last updated: November 29, 2023
Sponsor: LG Chem
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

TX322049
LG-GDCL-010
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A randomized, multi-regional, double-blind, double dummy parallel-group Phase 3 study to assess the efficacy and safety of study medication in Gout patients with Hyperuricemia.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Hyperuricemia and history of or presence of gout (at least one flare up in the last year)
  • BMI <50 kg
  • Male or Female 18-85 years old
  • No history of heart attack or stroke
  • No history of cancer in the last 5 years
  • No uncontrolled severe pain (e.g. severe osteoarthritis, back pain)

Study Design

Study Start date:
November 17, 2023
Estimated Completion Date:

Study Description

The estimated duration of the study will be 12.5 to 13.5 months. The study includes Screening (1 week-1 visit), washout and gout flare prophylaxis period (1 month- 2 visits), Treatment period (12 months- 13 visits), and safety follow-up (0.5 month- 1visit) for a total of 17 visits.

Connect with a study center

  • Elite Clinical Studies

    Phoenix, AZ 85018
    United States

    Active - Recruiting

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