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Does Allopurinol Prolong a Treated, Acute Gout Flare?

Primary Purpose

Gout

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
allopurinol
Placebo (sugar pill)
Sponsored by
59th Medical Wing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • Wilford Hall Ambulatory Surgical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allopurinol

Sugar pill (Placebo)

Arm Description

Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days

Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain Day 28
Patient rated pain on a Likert pain score of 0-10
Physician Global Assessment of Gout Activity at Day 28
Physician rated gout activity is measured on a Likert scale 0-10.
Serum Uric Acid Level
Blood test (serum) for uric acid level

Full Information

First Posted
November 6, 2013
Last Updated
January 18, 2018
Sponsor
59th Medical Wing
Collaborators
United States Air Force
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1. Study Identification

Unique Protocol Identification Number
NCT01988402
Brief Title
Does Allopurinol Prolong a Treated, Acute Gout Flare?
Official Title
Does Allopurinol Prolong a Treated, Acute Gout Flare?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
59th Medical Wing
Collaborators
United States Air Force

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol
Arm Type
Active Comparator
Arm Description
Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days
Arm Title
Sugar pill (Placebo)
Arm Type
Placebo Comparator
Arm Description
Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Intervention Type
Drug
Intervention Name(s)
allopurinol
Intervention Type
Drug
Intervention Name(s)
Placebo (sugar pill)
Primary Outcome Measure Information:
Title
Resolution of the Acute Gout Attack
Description
The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
Time Frame
1-28 Days
Secondary Outcome Measure Information:
Title
Pain Day 28
Description
Patient rated pain on a Likert pain score of 0-10
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
Title
Physician Global Assessment of Gout Activity at Day 28
Description
Physician rated gout activity is measured on a Likert scale 0-10.
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
Title
Serum Uric Acid Level
Description
Blood test (serum) for uric acid level
Time Frame
day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay B Higgs, MD
Organizational Affiliation
59th Medical Wing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilford Hall Ambulatory Surgical Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States

12. IPD Sharing Statement

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Does Allopurinol Prolong a Treated, Acute Gout Flare?

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