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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01310673
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : March 8, 2011
Information provided by:
White River Junction Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Gout Gout Acute Drug: Allopurinol Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapy for Acute Gout: Does Initial Use of Allopurinol Effect Duration and/or Recurrence Rate of Acute Attacks
Study Start Date : January 1998
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
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.

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.

Primary Outcome Measures :
  1. Daily pain scores and recurrence attack rate. [ Time Frame: 30 days after initiation of treatment ]

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

    Patient reported gout recurrences over 30 days

Secondary Outcome Measures :
  1. sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits [ Time Frame: 30 days ]
    Fall in ESR and CRP were measured as confirmation of attack resolution

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01310673

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United States, Vermont
White River Junction VA Medical Center
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
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Principal Investigator: Thomas H Taylor, MD White River Junction VA Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Thomas H. Taylor MD, Chief Rheumatology and Infectious Diseases, White River Junction VA Hospital Identifier: NCT01310673    
Other Study ID Numbers: CPHS #16820
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011
Keywords provided by White River Junction Veterans Affairs Medical Center:
Acute gout
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs