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Completed

NCT Number: NCT01310673

Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout

Medical teaching suggests allopurinol should not be initiated in the setting of an acute attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests the hypothesis that there is no difference in patient reported daily pain or flair occurrences with early versus delayed institution of allopurinol during an acute gout attack.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

White River Junction VA Medical Center

White River Junction, Vermont, 05009, United States

About this study

Design: Randomized, placebo-controlled, double-blind trial. Setting: Outpatient clinics, White River Junction Veterans Affairs Medical Center.

Patients: 57 men with crystal proven acute gout attack, at first medical contact, and within 7 days onset.

Intervention: Subjects were randomized to receive allopurinol 300mg daily or matching placebo for 10 days. All patients received indomethacin 50mg TID for 10 days, prophylactic dose colchicine 0.6mg BID for 90 days, and open-label allopurinol starting at day 11.

Measurements: Primary outcomes were patient reported pain on visual analogue scale (VAS) for the primary joint, and self reported flares in any joint days 1-30. Secondary endpoints included urate, sedimentation rates, C-reactive protein levels.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • First medical contact for acute attack of gout.
  • ACR criteria for acute attack of gout
  • Crystal proven by arthrocentesis on day of enrollment
  • Primary gout

Exclusion criteria

  • Secondary Gout
  • Tophaceous Gout
  • Prior steroid, colchicine, or uric acid lowering therapy in the past 6 months.
  • Uncontrolled CHF
  • Unstable angina
  • Renal insufficiency (entry CREAT > 1.3)
  • Anticoagulant therapy
  • Immunosuppressive therapy or chemotherapy in the past 6 months
  • Pregnancy; OR
  • Known allergy to NSAID, colchicine, or allopurinol

Treatment and study plan

Allopurinol

Drug

Allopurinol 300mg po QD for 30 days.

Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days.

Placebo

Drug

Placebo tablet QD for 10 days, followed by delayed allopurinol 300mg po QD days 11-30.

Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days.

Primary outcomes

  1. Daily pain scores and recurrence attack rate.

    Time frame: 30 days after initiation of treatment

    Daily pain measured on a visual analogue scale over 10 days after initiation of treatment.

    Patient reported gout recurrences over 30 days

Secondary outcomes

  1. sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits

    Time frame: 30 days

    Fall in ESR and CRP were measured as confirmation of attack resolution

Sponsors and collaborators

Lead sponsor

White River Junction Veterans Affairs Medical Center

Fed

Registry information

Official study title

Therapy for Acute Gout: Does Initial Use of Allopurinol Effect Duration and/or Recurrence Rate of Acute Attacks

Important dates

Study start
1998
Primary completion
2009
Study completion
2009
First posted
Mar 8, 2011
Registry last updated
Mar 8, 2011

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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