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

NCT ID: NCT01310673

Last Updated: 2011-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-01-31
• Study Completion Date: 2009-07-31

Brief 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.

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.

Conditions

Gout; Gout Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Allopurinol

Group Type: ACTIVE_COMPARATOR

Allopurinol

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Allopurinol

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

White River Junction Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

White River Junction VA Hospital

Principal Investigators

Thomas H Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

White River Junction VA Medical Center

Locations

White River Junction VA Medical Center

White River Junction, Vermont, United States

Countries

United States

References

Taylor TH, Mecchella JN, Larson RJ, Kerin KD, Mackenzie TA. Initiation of allopurinol at first medical contact for acute attacks of gout: a randomized clinical trial. Am J Med. 2012 Nov;125(11):1126-1134.e7. doi: 10.1016/j.amjmed.2012.05.025.

Reference Type: DERIVED

PMID: 23098865 (View on PubMed)

Other Identifiers

CPHS #16820

Identifier Type: -

Identifier Source: org_study_id