Does Allopurinol Prolong a Treated, Acute Gout Flare?

This is a double blind placebo controlled study to determine whether starting allopurinol during a treated acute gout attack will have any effect on the duration of the attack.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: allopurinol; Drug: Placebo (sugar pill)

Detailed Description

Traditional teaching holds that starting allopurinol during an acute gout attack will prolong the attack. Recent expert opinion from the American College of Rheumatology Guidelines is that allopurinol may be started during an acute, treated gout attack. This study is designed to test the hypothesis that allopurinol does not prolong an acute, treated gout attack. Patients will either take allopurinol capsules or and identical capsule containing no allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack that is being treated with other standard measures. During the study, neither the patient nor the examiner will know what pills are being taken. The time to resolution of the attack is the primary outcome measure. Pain level, serum uric acid level, and complications of therapy will also be monitored. A minimum of 32 patients completing the study are needed for a meaningful conclusion.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lackland Air Force Base, Texas, United States, 78236
      • Wilford Hall Ambulatory Surgical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria requires both of:

• Crystal proven gout, and
• An acute gout attack within 72 hours of first treatment

Plus one of the following:

• At least 2 gout attacks in past 12 months
• Tophus
• Nephrolithiasis
• 24hr urine uric acid greater than 1000mg

Exclusion Criteria:

• Inability to return for examinations
• Glomerular filtration rate (calculated) less than 50 milliliters per minute
• Allopurinol use in past 6 months
• Ongoing cancer therapy
• Concomitant azathioprine or cyclophosphamide

• Any one of the following liver enzymes greater than 1.25 times the upper limit of normal:

  • AST [Aspartate aminotransferase]
  • ALT [Alanine aminotransferase]
  • alkaline phosphatase
• Pre-gout pain in involved joint of more than 3 on a scale of 1-10
• Neurologic deficit around the involved joint

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Allopurinol; Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days	Drug: allopurinol
Placebo Comparator: Sugar pill (Placebo); Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.	Drug: Placebo (sugar pill)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of the Acute Gout Attack	The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack	1-28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Day 28	Patient rated pain on a Likert pain score of 0-10	Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
Physician Global Assessment of Gout Activity at Day 28	Physician rated gout activity is measured on a Likert scale 0-10.	Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
Serum Uric Acid Level	Blood test (serum) for uric acid level	day 28

Collaborators and Investigators

• Sponsor: 59th Medical Wing
• Collaborators: United States Air Force
• Investigators: Principal Investigator: Jay B Higgs, MD, 59th Medical Wing

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 13, 2013
• First Posted (Estimate): November 20, 2013

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: allopurinol; gout
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol
• Other Study ID Numbers: FWH20070235H