NCT01736514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

November 27, 2012

Last Update Submit

October 28, 2014

Conditions

Gout

Keywords

xanthine oxidase inhibitorUric acid lowering drug

Outcome Measures

Primary Outcomes (1)

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

    week 12

Secondary Outcomes (2)

  • Percent reduction in serum urate levels

    Baseline and at week 12

  • Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG

    Baseline and at week 12

Study Arms (2)

febuxostat group

EXPERIMENTAL

oral

Drug: febuxostat

allopurinol group

ACTIVE COMPARATOR

oral

Drug: Allopurinol

Interventions

febuxostatDRUG

oral

Also known as: Adenuric, Uloric, Feburic
febuxostat group
AllopurinolDRUG

oral

allopurinol group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Linkou District, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

Gout

Interventions

FebuxostatAllopurinol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Medical Director

    Astellas Pharma Taiwan, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

March 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

TW(4)