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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310673
• Other study ID #: CPHS #16820
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2011
• Last updated: March 7, 2011
• Start date: January 1998
• Est. completion date: July 2009

Study information

• Verified date: March 2011
• Source: White River Junction VAMC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout
• Gout Acute

Intervention

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
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.

Locations

Country	Name	City	State
United States	White River Junction VA Medical Center	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
White River Junction VAMC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No