Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment
A Phase 2, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of Febuxostat 40 mg XR, 80 mg XR, 40 mg IR and 80 mg IR in Subjects With Gout and Moderate Renal Impairment
2 other identifiers
interventional
189
1 country
89
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in gout participants with moderate renal impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2014
Shorter than P25 for phase_2
89 active sites
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
First Submitted
Initial submission to the registry
April 29, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
November 3, 2016
CompletedNovember 3, 2016
September 1, 2016
1.3 years
April 29, 2014
September 15, 2016
September 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3
Month 3
Secondary Outcomes (2)
Percentage of Participants With at Least One Gout Flare Requiring Treatment
Baseline to Month 3
Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3
Month 3
Study Arms (5)
Febuxostat IR 40 mg
ACTIVE COMPARATORFebuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Febuxostat IR 80 mg
ACTIVE COMPARATORFebuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Febuxostat XR 40 mg
EXPERIMENTALFebuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Febuxostat XR 80 mg
EXPERIMENTALFebuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Placebo
PLACEBO COMPARATORFebuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Interventions
Febuxostat IR over-encapsulated tablets
Colchicine tablets
Naproxen tablets
Lansoprazole capsules
Eligibility Criteria
You may qualify if:
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedure.
- Has a history or presence of gout defined as having one or more of the American Rheumatism Association (ARA) criteria for the diagnosis of gout:
- A tophus proven to contain urate crystals by chemical or polarized light microscopic means, AND/OR;
- Characteristic urate crystals in the joint fluid, AND/OR;
- History of at least 6 of the following clinical, laboratory, and x-ray phenomena:
- i. more than one attack of acute arthritis, ii. maximum inflammation developed within 1 day, iii. monoarticular arthritis, iv. redness observed over joints, v. first metatarsophalangeal joint painful or swollen, vi. unilateral first metatarsophalangeal joint attack, vii. unilateral tarsal joint attack, viii. tophus (proven or suspected), ix. Hyperuricemia, x. asymmetric swelling within a joint on x-ray, xi. subcortical cysts without erosions on x-ray, xii. joint fluid culture negative for organisms during attack.
- Is male or female at least 18 years of age, inclusive.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
- Have a serum urate (sUA) level ≥8.0 mg/dL at the Day -4 Visit or at the retest visit.
- Has an estimated Glomerular Filtration Rate (eGRF) \[Modification of Diet in Renal Disease (MDRD)\] ≥30 mL/min and \<60 mL/min at Screening visit (Day -21 for participants on urate lowering therapy (ULT) and Day -4 for participants not on ULT) or at the retest visit.
- Has at least one gout flare within 12 months prior to Screening visit.
You may not qualify if:
- Has received any investigational compound within 30 days prior to Screening.
- Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Is breastfeeding or pregnant.
- Has secondary hyperuricemia (eg, due to myeloproliferative disorder).
- Has a history of xanthinuria.
- Has received ULT (ie, allopurinol, probenecid, etc.) within 20 days prior to Day 1/Randomization Visit.
- Has a known hypersensitivity to febuxostat or any components of their formulation; has a known hypersensitivity to naproxen, any other nonsteroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine or any components in their formulation.
- Has active peptic ulcer disease.
- Has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the Screening Visit.
- Has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values \>2 x the upper limit of normal (ULN).
- Has rheumatoid arthritis which requires treatment.
- Has a significant medical condition and/or conditions that would interfere with the treatment, safety, or compliance with the protocol.
- Has experienced either a myocardial infarction (MI), stroke, hospitalized unstable angina, cardiac or cerebrovascular revascularization procedure or hospitalized transient ischemic attack (TIA).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the Screening visit. Participant consumes \>14 alcoholic beverages/week.
- Has participated in another investigational study within the 30 days prior to the Screening Visit.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (89)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Benny Green MD PA Family Practice
Little Rock, Arkansas, 72223, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Bellflower, California, United States
Unknown Facility
Escondido, California, United States
Unknown Facility
Harbor City, California, United States
Unknown Facility
Huntington Park, California, United States
Unknown Facility
Irvine, California, United States
Unknown Facility
Lomita, California, United States
Long Beach Center for Clinical Research
Long Beach, California, 90807, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Brigid Freyne MD
Murrieta, California, 92563, United States
Unknown Facility
Murrieta, California, United States
Unknown Facility
Orange, California, United States
Unknown Facility
Rancho Cucamonga, California, United States
Unknown Facility
Redondo Beach, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Jose, California, United States
Unknown Facility
San Ramon, California, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Coral Gables, Florida, United States
Unknown Facility
Coral Springs, Florida, United States
Riverside Clinical Research
Edgewater, Florida, 32141, United States
Unknown Facility
Edgewater, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Miami Beach, Florida, United States
Unknown Facility
Miami Lakes, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Plantation, Florida, United States
Unknown Facility
Port Charlotte, Florida, United States
Unknown Facility
Saint Cloud, Florida, United States
Unknown Facility
Vero Beach, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Dunwoody, Georgia, United States
Unknown Facility
East Point, Georgia, United States
Unknown Facility
Suwanee, Georgia, United States
East West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Unknown Facility
Honolulu, Hawaii, United States
Unknown Facility
Brownsburg, Indiana, United States
Unknown Facility
Manhattan, Kansas, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Elizabethtown, Kentucky, United States
Central Kentucy Reseach Associates
Lexington, Kentucky, 40509, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Paducah, Kentucky, United States
Unknown Facility
Mandeville, Louisiana, United States
Unknown Facility
Metairie, Louisiana, United States
Unknown Facility
Fall River, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Hazelwood, Missouri, United States
Unknown Facility
Washington, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Columbiana, North Carolina, United States
Unknown Facility
Greensboro, North Carolina, United States
Unknown Facility
Salisbury, North Carolina, United States
Unknown Facility
Wilmington, North Carolina, United States
Unknown Facility
Fargo, North Dakota, United States
Unknown Facility
Franklin, Ohio, United States
COR Clinical Research LLC
Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Old Point Station, South Carolina, United States
Unknown Facility
Clarksville, Tennessee, United States
Unknown Facility
Knoxville, Tennessee, United States
Remesh C Gupta MD
Memphis, Tennessee, 38119, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Bellaire, Texas, United States
3rd Coast Research Associates
Corpus Christi, Texas, 78413, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Nassau Bay, Texas, United States
Unknown Facility
Plano, Texas, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Briggs Clinical Research LLC
San Antonio, Texas, 78224, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Bountiful, Utah, United States
Unknown Facility
Newport News, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Virginia Beach, Virginia, United States
Related Publications (1)
Gunawardhana L, Becker MA, Whelton A, Hunt B, Castillo M, Saag K. Efficacy and safety of febuxostat extended release and immediate release in patients with gout and moderate renal impairment: phase II placebo-controlled study. Arthritis Res Ther. 2018 May 30;20(1):99. doi: 10.1186/s13075-018-1593-0.
PMID: 29848361DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2014
First Posted
May 1, 2014
Study Start
May 1, 2014
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
November 3, 2016
Results First Posted
November 3, 2016
Record last verified: 2016-09