Trial record 15 of 115 for:    "Gout"

Does Allopurinol Prolong a Treated, Acute Gout Flare?

This study has been completed.
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Jay B. Higgs, MD, Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT01988402
First received: November 6, 2013
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Gout
Drug: allopurinol
Drug: Placebo (sugar pill)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Allopurinol Prolong a Treated, Acute Gout Flare?

Resource links provided by NLM:


Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack [ Time Frame: 1-28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in patient rated pain over time [ Time Frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28 ] [ Designated as safety issue: Yes ]
    Patient rated pain on a Likert pain score of 1-10

  • Change in physician global assessment of gout activity [ Time Frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28 ] [ Designated as safety issue: Yes ]
    Physician rated gout activity on a Likert scale 1-10.

  • Change in serum uric acid level [ Time Frame: Pre-study and at day 28 ] [ Designated as safety issue: No ]
    Blood test (serum) for uric acid level


Enrollment: 37
Study Start Date: December 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988402

Locations
United States, Texas
Wilford Hall Ambulatory Surgical Center
Lackland AFB, 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
  More Information

No publications provided

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
Study First Received: November 6, 2013
Last Updated: November 13, 2013
Health Authority: United States: Federal Government

Keywords provided by Wilford Hall Medical Center:
gout
allopurinol

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

ClinicalTrials.gov processed this record on August 28, 2014