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Does Allopurinol Prolong a Treated, Acute Gout Flare?

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ClinicalTrials.gov Identifier: NCT01988402
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : January 5, 2015
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Jay B. Higgs, MD, Wilford Hall Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Gout Drug: allopurinol Drug: Placebo (sugar pill) Phase 4

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  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Allopurinol Prolong a Treated, Acute Gout Flare?
Study Start Date : December 2007
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout
U.S. FDA Resources

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)



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988402


Locations
United States, Texas
Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, United States, 78236
Sponsors and Collaborators
Wilford Hall Medical Center
United States Air Force
Investigators
Principal Investigator: Jay B Higgs, MD Wilford Hall Ambulatory Surgical Center

Responsible Party: Jay B. Higgs, MD, Program Director, Rheumatology Fellowship, Wilford Hall Medical Center
ClinicalTrials.gov Identifier: NCT01988402     History of Changes
Other Study ID Numbers: FWH20070235H
First Posted: November 20, 2013    Key Record Dates
Results First Posted: January 5, 2015
Last Update Posted: February 14, 2018
Last Verified: January 2018

Keywords provided by Jay B. Higgs, MD, Wilford Hall Medical Center:
gout
allopurinol

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs