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

Primary Purpose

Gout

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
febuxostat
Allopurinol
Sponsored by
Astellas Pharma Taiwan, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring xanthine oxidase inhibitor, Uric acid lowering drug

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

febuxostat group

allopurinol group

Arm Description

oral

oral

Outcomes

Primary Outcome Measures

Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL

Secondary Outcome Measures

Percent reduction in serum urate levels
Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG

Full Information

First Posted
November 27, 2012
Last Updated
October 28, 2014
Sponsor
Astellas Pharma Taiwan, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01736514
Brief Title
A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout
Official Title
A Randomized, Open Label, Multicenter, Allopurinol- Controlled Study to Assess the Safety and Efficacy of Oral Febuxostat in Patients With Gout
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Taiwan, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
xanthine oxidase inhibitor, Uric acid lowering drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
febuxostat group
Arm Type
Experimental
Arm Description
oral
Arm Title
allopurinol group
Arm Type
Active Comparator
Arm Description
oral
Intervention Type
Drug
Intervention Name(s)
febuxostat
Other Intervention Name(s)
Adenuric, Uloric, Feburic
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
oral
Primary Outcome Measure Information:
Title
Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Percent reduction in serum urate levels
Time Frame
Baseline and at week 12
Title
Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG
Time Frame
Baseline and at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Taiwan, Inc.
Official's Role
Study Director
Facility Information:
City
Kaohsiung
Country
Taiwan
City
Linkou
Country
Taiwan
City
Taichung
Country
Taiwan
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140644 in the JapicCTI-RNo. field

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

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