Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout
NCT ID: NCT02139046
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1790 participants
INTERVENTIONAL
2014-04-30
2015-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will enroll approximately 1750 patients. Participants will be randomly assigned (by chance) to one of the five treatment groups-which will remain undisclosed to the patient 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 day or every other day, or naproxen 250 mg twice a day and lansoprazole 15 mg once a day to prevent gout flare ups.
This multi-centre 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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Febuxostat IR 40 mg
Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, 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 day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, 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 day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Febuxostat XR
Febuxostat XR 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 day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Febuxostat XR
Febuxostat XR 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 day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Febuxostat placebo
Febuxostat placebo-matching capsules
Colchicine
Colchicine tablets
Naproxen
Naproxen tablets
Lansoprazole
Lansoprazole capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Febuxostat IR
Febuxostat IR over-encapsulated tablets
Febuxostat XR
Febuxostat XR over-encapsulated capsules
Febuxostat placebo
Febuxostat placebo-matching capsules
Colchicine
Colchicine tablets
Naproxen
Naproxen tablets
Lansoprazole
Lansoprazole capsules
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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) ≥15 mL/min using the Modification of Diet in Renal Disease (MDRD) formula at the 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 dependent 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 a myocardial infarction (MI), stroke, hospitalized unstable angina, cardiac or cerebrovascular revascularization procedure or hospitalized transient ischemic attack (TIA) - except in participants who have severe renal impairment.
14. Participants with severe renal impairment had a MI or stroke within 90 days prior to initial screening visit or has a MI or stroke during the screening period prior to Day 1/Randomization Visit.
15. Participant consumes \>14 alcoholic beverages/week. Has a history of alcoholism or illicit drug abuse within 5 years.
16. Has participated in another investigational study within the 30 days prior to the Screening Visit.
17. Has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
18. Is required to take excluded medications.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Ramon, California, United States
Santa Clarita, California, United States
Tustin, California, United States
Upland, California, United States
Binghamton, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
Little Rock, Arkansas, United States
Searcy, Arkansas, United States
Bellflower, California, United States
Carmichael, California, United States
Costa Mesa, California, United States
Covina, California, United States
El Cajon, California, United States
Encinitas, California, United States
Encino, California, United States
Escondido, California, United States
Gold River, California, United States
Irvine, California, United States
Lancaster, California, United States
Lomita, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Monterey Park, California, United States
Murrieta, California, United States
North Hollywood, California, United States
Norwalk, California, United States
Paramount, California, United States
Rancho Cucamonga, California, United States
Riverside, California, United States
Roseville, California, United States
Sacramento, California, United States
San Diego, California, United States
San Jose, California, United States
Arvada, Colorado, United States
Westminster, Colorado, United States
Wheat Ridge, Colorado, United States
Lewes, Delaware, United States
Boynton Beach, Florida, United States
Brandon, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Coral Springs, Florida, United States
Daytona Beach, Florida, United States
DeLand, Florida, United States
Doral, Florida, United States
Edgewater, Florida, United States
Fort Lauderdale, Florida, United States
Fort Meyers, Florida, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Homestead, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
North Bay Village, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Plant City, Florida, United States
Port Charlotte, Florida, United States
Sanford, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Columbus, Georgia, United States
Dunwoody, Georgia, United States
Fort Valley, Georgia, United States
Marietta, Georgia, United States
Newnan, Georgia, United States
Norcross, Georgia, United States
Roswell, Georgia, United States
Savannah, Georgia, United States
Suwanee, Georgia, United States
Honolulu, Hawaii, United States
Meridian, Idaho, United States
Gurnee, Illinois, United States
Avon, Indiana, United States
Brownsburg, Indiana, United States
Newburgh, Indiana, United States
Augusta, Kansas, United States
Wichita, Kansas, United States
Crestview Hills, Kentucky, United States
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Paducah, Kentucky, United States
Baker, Louisiana, United States
Lafayette, Louisiana, United States
Mandeville, Louisiana, United States
Metairie, Louisiana, United States
Biddeford, Maine, United States
Columbia, Maryland, United States
Frederick, Maryland, United States
Oxon Hill, Maryland, United States
Brockton, Massachusetts, United States
Fall River, Massachusetts, United States
Buckley, Michigan, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Biloxi, Mississippi, United States
Olive Branch, Mississippi, United States
Hazelwood, Missouri, United States
Washington, Missouri, United States
Billings, Montana, United States
Missoula, Montana, United States
Bellevue, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Lodi, New Jersey, United States
Teaneck, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Endwell, New York, United States
Manhasset, New York, United States
Columbiana, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Chagrin Falls, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Lyndhurst, Ohio, United States
Mentor, Ohio, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Wadsworth, Ohio, United States
Willoughby Hills, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Altoona, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Lansdale, Pennsylvania, United States
McMurray, Pennsylvania, United States
Media, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Rapid City, South Dakota, United States
Bristol, Tennessee, United States
Collierville, Tennessee, United States
Jackson, Tennessee, United States
Memphis, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Bellaire, Texas, United States
Carrollton, Texas, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
The Woodlands, Texas, United States
Bountiful, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Alexandria, Virginia, United States
Arlington, Virginia, United States
Burke, Virginia, United States
Charlottesville, Virginia, United States
Danville, Virginia, United States
Midlothian, Virginia, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Sterling, Virginia, United States
Spokane, Washington, United States
Clarksburg, West Virginia, United States
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Saag KG, Becker MA, Whelton A, Hunt B, Castillo M, Kisfalvi K, Gunawardhana L. Efficacy and Safety of Febuxostat Extended and Immediate Release in Patients With Gout and Renal Impairment: A Phase III Placebo-Controlled Study. Arthritis Rheumatol. 2019 Jan;71(1):143-153. doi: 10.1002/art.40685.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1152-4040
Identifier Type: OTHER
Identifier Source: secondary_id
FEB-XR_301
Identifier Type: -
Identifier Source: org_study_id