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

This study has been completed.
Sponsor:
Information provided by:
White River Junction VAMC
ClinicalTrials.gov Identifier:
NCT01310673
First received: March 7, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 7, 2011
March 7, 2011
January 1998
July 2009   (final data collection date for primary outcome measure)
Daily pain scores and recurrence attack rate. [ Time Frame: 30 days after initiation of treatment ] [ Designated as safety issue: No ]

Daily pain measured on a visual analogue scale over 10 days after initiation of treatment.

Patient reported gout recurrences over 30 days
Same as current
No Changes Posted
sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Fall in ESR and CRP were measured as confirmation of attack resolution
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gout
  • Gout Acute
  • 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.

  • 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
    Intervention: Drug: Allopurinol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01310673
CPHS #16820
No
Thomas H. Taylor MD, Chief Rheumatology and Infectious Diseases, White River Junction VA Hospital
White River Junction VAMC
Not Provided
Principal Investigator: Thomas H Taylor, MD White River Junction VA Medical Center
White River Junction VAMC
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP