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
1 other identifier
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 1998
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedMarch 8, 2011
March 1, 2011
11.5 years
March 7, 2011
March 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits
30 days
Study Arms (2)
Allopurinol
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
White River Junction VA Medical Center
White River Junction, Vermont, 05009, United States
Related Publications (1)
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.
PMID: 23098865DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas H Taylor, MD
White River Junction VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 8, 2011
Study Start
January 1, 1998
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 8, 2011
Record last verified: 2011-03