Does Allopurinol Prolong a Treated, Acute Gout Flare?

Gout Clinical Trial

Official title:

Does Allopurinol Prolong a Treated, Acute Gout Flare?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988402
• Other study ID #: FWH20070235H
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2013
• Last updated: January 18, 2018
• Start date: December 2007
• Est. completion date: June 2013

Study information

• Verified date: January 2018
• Source: Wilford Hall Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• allopurinol

• Placebo (sugar pill)

Locations

Country	Name	City	State
United States	Wilford Hall Ambulatory Surgical Center	Lackland Air Force Base	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Wilford Hall Medical Center	United States Air Force

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Serum Uric Acid Level	Blood test (serum) for uric acid level	day 28