Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment
NCT ID: NCT02128490
Last Updated: 2016-11-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
189 participants
INTERVENTIONAL
2014-05-31
2015-10-31
Brief Summary
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Detailed Description
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The study will enroll approximately 200 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
* Febuxostat 40 mg XR
* Febuxostat 80 mg XR
* Febuxostat 40 mg IR
* Febuxostat 80 mg IR
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.
All participants will be asked to take one capsule at the same time each day throughout the study, and will be asked to call an interactive voice response system any time they are having a gout flare up. In addition to study medication, participants will also take 0.6 mg of colchicine every other day or naproxen 250 mg twice a day with lansoprazole 15 mg once a day to prevent gout flare ups.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is up to approximately 4 months and participants will make up to 7 visits to the clinic.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Febuxostat IR 40 mg
Febuxostat 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
Febuxostat IR over-encapsulated tablets
Colchicine
Colchicine tablets
Naproxen
Naproxen tablets
Lansoprazole
Lansoprazole capsules
Febuxostat IR 80 mg
Febuxostat 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 IR
Febuxostat IR over-encapsulated tablets
Colchicine
Colchicine tablets
Naproxen
Naproxen tablets
Lansoprazole
Lansoprazole capsules
Febuxostat XR 40 mg
Febuxostat 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
Febuxostat over-encapsulated capsules
Colchicine
Colchicine tablets
Naproxen
Naproxen tablets
Lansoprazole
Lansoprazole capsules
Febuxostat XR 80 mg
Febuxostat 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.
Febuxostat XR
Febuxostat over-encapsulated capsules
Colchicine
Colchicine tablets
Naproxen
Naproxen tablets
Lansoprazole
Lansoprazole capsules
Placebo
Febuxostat 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.
Febuxostat placebo
Febuxostat IR and XR placebo-matching capsules
Colchicine
Colchicine tablets
Naproxen
Naproxen tablets
Lansoprazole
Lansoprazole capsules
Interventions
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Febuxostat IR
Febuxostat IR over-encapsulated tablets
Febuxostat XR
Febuxostat over-encapsulated capsules
Febuxostat placebo
Febuxostat IR and XR placebo-matching capsules
Colchicine
Colchicine tablets
Naproxen
Naproxen tablets
Lansoprazole
Lansoprazole capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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:
1. A tophus proven to contain urate crystals by chemical or polarized light microscopic means, AND/OR;
2. Characteristic urate crystals in the joint fluid, AND/OR;
3. 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.
4. Is male or female at least 18 years of age, inclusive.
5. 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.
6. Have a serum urate (sUA) level ≥8.0 mg/dL at the Day -4 Visit or at the retest visit.
7. 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.
8. Has at least one gout flare within 12 months prior to Screening visit.
Exclusion Criteria
2. 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.
3. Is breastfeeding or pregnant.
4. Has secondary hyperuricemia (eg, due to myeloproliferative disorder).
5. Has a history of xanthinuria.
6. Has received ULT (ie, allopurinol, probenecid, etc.) within 20 days prior to Day 1/Randomization Visit.
7. 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.
8. Has active peptic ulcer disease.
9. Has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the Screening Visit.
10. Has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values \>2 x the upper limit of normal (ULN).
11. Has rheumatoid arthritis which requires treatment.
12. Has a significant medical condition and/or conditions that would interfere with the treatment, safety, or compliance with the protocol.
13. Has experienced either a myocardial infarction (MI), stroke, hospitalized unstable angina, cardiac or cerebrovascular revascularization procedure or hospitalized transient ischemic attack (TIA).
14. 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.
15. Has participated in another investigational study within the 30 days prior to the Screening Visit.
16. Has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
17. Is required to take excluded medications.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham, Alabama, United States
Muscle Shoals, Alabama, United States
Phoenix, Arizona, United States
Benny Green MD PA Family Practice
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Bellflower, California, United States
Escondido, California, United States
Harbor City, California, United States
Huntington Park, California, United States
Irvine, California, United States
Lomita, California, United States
Long Beach Center for Clinical Research
Long Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Brigid Freyne MD
Murrieta, California, United States
Murrieta, California, United States
Orange, California, United States
Rancho Cucamonga, California, United States
Redondo Beach, California, United States
Sacramento, California, United States
San Jose, California, United States
San Ramon, California, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Coral Springs, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
Edgewater, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Port Charlotte, Florida, United States
Saint Cloud, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Dunwoody, Georgia, United States
East Point, Georgia, United States
Suwanee, Georgia, United States
East West Medical Research Institute
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Brownsburg, Indiana, United States
Manhattan, Kansas, United States
Wichita, Kansas, United States
Elizabethtown, Kentucky, United States
Central Kentucy Reseach Associates
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Paducah, Kentucky, United States
Mandeville, Louisiana, United States
Metairie, Louisiana, United States
Fall River, Massachusetts, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Hazelwood, Missouri, United States
Washington, Missouri, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Columbiana, North Carolina, United States
Greensboro, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Franklin, Ohio, United States
COR Clinical Research LLC
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Columbia, South Carolina, United States
Greer, South Carolina, United States
Old Point Station, South Carolina, United States
Clarksville, Tennessee, United States
Knoxville, Tennessee, United States
Remesh C Gupta MD
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Bellaire, Texas, United States
3rd Coast Research Associates
Corpus Christi, Texas, United States
Corpus Christi, Texas, United States
Nassau Bay, Texas, United States
Plano, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Briggs Clinical Research LLC
San Antonio, Texas, United States
San Antonio, Texas, United States
Bountiful, Utah, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Countries
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References
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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.
Other Identifiers
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U1111-1152-3942
Identifier Type: OTHER
Identifier Source: secondary_id
FEB-XR_201
Identifier Type: -
Identifier Source: org_study_id