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

Information source: White River Junction VAMC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gout; Gout Acute

Intervention: Allopurinol (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: White River Junction VAMC

Official(s) and/or principal investigator(s):
Thomas H Taylor, MD, Principal Investigator, Affiliation: White River Junction VA Medical Center

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Daily pain scores and recurrence attack rate.

Secondary outcome: sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Locations and Contacts

White River Junction VA Medical Center, White River Junction, Vermont 05009, United States
Additional Information

Starting date: January 1998
Last updated: March 7, 2011

Page last updated: August 23, 2015

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