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

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

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.

Study Overview

• Status: Completed
• Conditions: Gout; Gout Acute
• Intervention / Treatment: Drug: Allopurinol; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • White River Junction VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	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.
ACTIVE_COMPARATOR: Allopurinol	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily pain scores and recurrence attack rate.	Daily pain measured on a visual analogue scale over 10 days after initiation of treatment. Patient reported gout recurrences over 30 days	30 days after initiation of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits	Fall in ESR and CRP were measured as confirmation of attack resolution	30 days

Collaborators and Investigators

• Sponsor: White River Junction Veterans Affairs Medical Center
• Investigators: Principal Investigator: Thomas H Taylor, MD, White River Junction VA Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 1998
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: March 7, 2011
• First Submitted That Met QC Criteria: March 7, 2011
• First Posted (ESTIMATE): March 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 8, 2011
• Last Update Submitted That Met QC Criteria: March 7, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Gout; Allopurinol; Acute gout
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol
• Other Study ID Numbers: CPHS #16820