Controlled study to investigate management methods of gout attack for gout patients with uric-acid lowering therapy

Not Applicable

• Conditions: Gout with Hyperuricemia

• Registration Number: JPRN-UMIN000008414
• Lead Sponsor: Clinical research consortium on uric acid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-12
• Study Completion: 2015-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who meet any of the sixteen criteria below are ineligible for the study: 1) Patients who have previous history of hypersensitivity to febuxostat; 2) Patients who have previous history of hypersensitivity to colchicine; 3) Patients who have previous history of hypersensitivity to NSAIDs or patients who have not been affected by NSAIDs; 4) Patients who had gout attack in the last two weeks; 5) Patients who have used any uric-acid lowering drugs in the last four weeks; 6) Patients with secondary hyperuricemia; 7) Patients who have twice as high AST or ALT as the hospital's reference value; 8) Patients with serum creatinine level of 2.0 mg/dL or higher; 9) Patients who have or have had past history of malignant tumor as a complication requiring treatment; 10) Patients who are being treated with either mercaptopurine hydrate or azathioprine; 11) Patients with peptic ulcer; 12) Patients with serious hematological disorder; 13) Patients with serious cardiac disorder; 14) Patients with aspirin-induced asthma or its previous history; 15) Patients who participated in another clinical study or clinical trial in the six months prior to the confirmation of eligibility; 16) Patients who the doctor in charge judges are ineligible for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate (percentage of the patients who needed analgesic treatment with NSAIDs or adrenal corticosteroid) of gout attack (predictors are not included) during "the treatment period" (the first twelve weeks of the study).

Secondary Outcome Measures

Name	Time	Method
- Frequency of occurrence (number of the patients who needed analgesic treatment with NSAIDs or adrenal corticosteroid) of gout attack (predictors are not included) during "the treatment period" (the first twelve weeks of the study); - Frequency of occurrence (Number of the patients who needed analgesic treatment with NSAIDs or adrenal corticosteroid) of gout attack (predictors are not included) during "the observation period" (entire period of the study); - Achievement rate of serum uric-acid level of 6.0 mg/dL or lower during "the observation period" (entire period of the study).