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OpenTrials
Completed

NCT Number: NCT01451645

Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol

The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.

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Key information

Conditions

Intercritical Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alabaster, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

include, but are not limited to the following:

  • Men and postmenopausal women between the ages of 18 and 70
  • Meets the ARA criteria for classification of acute gout
  • Tophi present and/or a history of gout attacks in 2 or 3 joints
  • Self-reported history of at least 2 gout flares in the prior 12 months
  • Serum uric acid greater than or equal to 7.5 mg/dL at the first visit

Exclusion criteria

Exclusion criteria

include, but are not limited to the following:

  • Patients with an acute gout flare within 2 weeks prior to the first visit
  • Patients with chronic, active gout with at least 1 continuously inflamed joint for at least 4 weeks
  • Patients with more than three joints affected by gout
  • History of intolerance or allergy to colchicine or allopurinol
  • Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than 3 months prior to entering the study
  • Use of colchicine less than 14 days prior to entering the study

Treatment and study plan

Colchicine (Colcrys®)

Drug

daily 0.6 mg colchicine dosing for 16 weeks

Placebo

Drug

daily placebo dosing for 16 weeks

Allopurinol

Drug

background therapy

Primary outcomes

  1. Number of Gout Flares Per Participant From Day 1 to Week 16

    Time frame: Day 1 to Week 16

Secondary outcomes

  1. Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16

    Time frame: Day 1 to Week 16

  2. Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16

    Time frame: Day 1 to Week 16

  3. Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16

    Time frame: Day 1 to Week 16

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2011
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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