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
  Purpose

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 Intervention Phase
Gout
Gout Acute
Drug: Allopurinol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by White River Junction VAMC:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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


Enrollment: 57
Study Start Date: January 1998
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310673

Locations
United States, Vermont
White River Junction VA Medical Center
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
White River Junction VAMC
Investigators
Principal Investigator: Thomas H Taylor, MD White River Junction VA Medical Center
  More Information

No publications provided by White River Junction VAMC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas H. Taylor MD, Chief Rheumatology and Infectious Diseases, White River Junction VA Hospital
ClinicalTrials.gov Identifier: NCT01310673     History of Changes
Other Study ID Numbers: CPHS #16820
Study First Received: March 7, 2011
Last Updated: March 7, 2011
Health Authority: United States: Federal Government

Keywords provided by White River Junction VAMC:
Gout
Allopurinol
Acute gout

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014