Does Allopurinol Prolong a Treated, Acute Gout Flare?

NCT01988402 | Completed Phase 4 Results

• 1 other identifier: FWH20070235H
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout

Keywords

gout; allopurinol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Day 28

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

• Physician Global Assessment of Gout Activity at Day 28

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

• Serum Uric Acid Level

  day 28

Study Arms (2)

Allopurinol

ACTIVE COMPARATOR

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

Drug: allopurinol

Sugar pill (Placebo)

PLACEBO COMPARATOR

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)

Interventions

allopurinol DRUG

Allopurinol

Placebo (sugar pill) DRUG

Sugar pill (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• hr urine uric acid greater than 1000mg

You may not qualify if:

• 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

Sponsors & Collaborators

• 59th Medical Wing: lead
• United States Air Force: collaborator

Study Sites (1)

Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, 78236, United States

Location

MeSH Terms

Conditions

Gout

Interventions

Allopurinol; Sugars

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Jay B Higgs,
• Organization: San Antonio Military Medical Center

jay.b.higgs.civ@mail.mil

2109160797

Study Officials

• Jay B Higgs, MD

  59th Medical Wing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Rheumatology Fellowship

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 14, 2018
• Results First Posted: January 5, 2015

Record last verified: 2018-01

Locations

US (1)