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
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