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Completed

NCT Number: NCT01988402

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, 78236, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allopurinol

Drug

Placebo (sugar pill)

Drug

Primary outcomes

  1. Resolution of the Acute Gout Attack

    Time frame: 1-28 Days

    The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack

Secondary outcomes

  1. Pain Day 28

    Time frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported

    Patient rated pain on a Likert pain score of 0-10

  2. Physician Global Assessment of Gout Activity at Day 28

    Time frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported

    Physician rated gout activity is measured on a Likert scale 0-10.

  3. Serum Uric Acid Level

    Time frame: day 28

    Blood test (serum) for uric acid level

Sponsors and collaborators

Lead sponsor

59th Medical Wing

Fed

Collaborators

  • United States Air Force

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Nov 20, 2013
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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