A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout

Gout Clinical Trial

Official title:

A Randomized, Open Label, Multicenter, Allopurinol- Controlled Study to Assess the Safety and Efficacy of Oral Febuxostat in Patients With Gout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736514
• Other study ID #: TMXALL-1001-TW
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2012
• Last updated: October 28, 2014
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: October 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study. Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or allopurinol for subjects with gout.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects will also have a history or presence of gout as defined by the American College of Rheumatology (ACR) criteria

• Subject has serum urate level >= 8.0 mg/dL at the screening Visit

Exclusion Criteria:

• Female subject who is breast-feeding or pregnant

• Subject has a history of xanthinuria

• Subject who is intolerant of allopurinol, ie hypersensitivity, Steven-Johnson syndrome/topic epidermal necrolysis

• Subject who takes allopurinol > 300 mg/day and with serum urate level > 8mg/dL

• Subject who is HLA B*5801 positive

• Subject who is receiving thiazide diuretic therapy

• Subject who has secondary hyperuricemia

• Subject who requires concurrent therapy with any systemic or topical medications, prescribed or non-prescribed, containing aspirin or other salicylates (low doses of aspirin will be allowed(ie. =< 325mg/day)

• Subject who requires therapy with prednisone > 10 mg/ day during the study

• Subject who has active liver disease or hepatic dysfunction, defined as both ALT and AST > 1.5 times the upper limit of normal

• Subject who has serum creatinine >= 1.5mg/dL

• Subject who has any another significant medical condition as defined by the investigator that would interfere with the treatment, safety or compliance with the protocol (eg. A clinically significant ECG result)

• Subject who has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the study, or has taken any systemic cancer chemotherapy within 5 years prior to the study

• Subject who has previously participated in a clinical study in which febuxostat was administered

• Subject who has participated in another investigational trial within the 30 days prior to the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• febuxostat
oral
• Allopurinol
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL		week 12	No
Secondary	Percent reduction in serum urate levels		Baseline and at week 12	No
Secondary	Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG		Baseline and at week 12	No

External Links

•   Link to Results on JAPIC - enter 140644 in the JapicCTI-RNo. field