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

Primary Purpose

Gout, Gout Acute

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Allopurinol
Placebo
Sponsored by
White River Junction Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring Gout, Allopurinol, Acute gout

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • White River Junction VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allopurinol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2011
Last Updated
March 7, 2011
Sponsor
White River Junction Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01310673
Brief Title
Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout
Official Title
Therapy for Acute Gout: Does Initial Use of Allopurinol Effect Duration and/or Recurrence Rate of Acute Attacks
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
White River Junction Veterans Affairs Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Gout Acute
Keywords
Gout, Allopurinol, Acute gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Daily pain scores and recurrence attack rate.
Description
Daily pain measured on a visual analogue scale over 10 days after initiation of treatment. Patient reported gout recurrences over 30 days
Time Frame
30 days after initiation of treatment
Secondary Outcome Measure Information:
Title
sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits
Description
Fall in ESR and CRP were measured as confirmation of attack resolution
Time Frame
30 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H Taylor, MD
Organizational Affiliation
White River Junction VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
White River Junction VA Medical Center
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23098865
Citation
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.
Results Reference
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Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout

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