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Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gout

Intervention: Febuxostat IR (Drug); Febuxostat XR (Drug); Febuxostat placebo (Drug); Colchicine (Drug); Naproxen (Drug); Lansoprazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Medical Director Clinical Science, Study Director, Affiliation: Takeda

Overall contact:
Takeda Study Registration Call Center, Phone: 800-778-2860, Email: medicalinformation@tpna.com

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 participants with gout.

Clinical Details

Official title: A Phase 3, 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Participants with Serum Urate <5.0 mg/dL at Month 3

Secondary outcome:

Percentage of Participants with at Least One Gout Flare Requiring Treatment

Percentage of Participants with Serum Urate <6.0 mg/dL at Month 3

Detailed description: The drug being tested in this study is called febuxostat. Febuxostat is being tested to decrease and maintain serum urate in people who have gout. This study will look at serum urate levels in people who take febuxostat extended release (XR) capsules compared to febuxostat immediate release (IR) capsules and placebo. 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 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: 1. Has received any investigational compound within 30 days prior to Screening. 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 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.

Locations and Contacts

Takeda Study Registration Call Center, Phone: 800-778-2860, Email: medicalinformation@tpna.com

Binghamton, Alabama, United States; Recruiting

Birmingham, Alabama, United States; Recruiting

Huntersville, Alabama, United States; Recruiting

Huntsville, Alabama, United States; Recruiting

Gilbert, Arizona, United States; Recruiting

Glendale, Arizona, United States; Recruiting

Phoenix, Arizona, United States; Recruiting

Tucson, Arizona, United States; Completed

Fayetteville, Arkansas, United States; Recruiting

Little Rock, Arkansas, United States; Recruiting

Searcy, Arkansas, United States; Recruiting

Bellflower, California, United States; Recruiting

Carmichael, California, United States; Recruiting

Costa Mesa, California, United States; Recruiting

Covina, California, United States; Recruiting

El Cajon, California, United States; Recruiting

Encinitas, California, United States; Recruiting

Encino, California, United States; Recruiting

Gold River, California, United States; Recruiting

Irvine, California, United States; Recruiting

Lancaster, California, United States; Recruiting

Lomita, California, United States; Recruiting

Long Beach, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Monterey Park, California, United States; Recruiting

Murrieta, California, United States; Recruiting

North Hollywood, California, United States; Recruiting

Norwalk, California, United States; Recruiting

Orange, California, United States; Recruiting

Paramount, California, United States; Recruiting

Rancho Cucamonga, California, United States; Recruiting

Riverside, California, United States; Recruiting

Roseville, California, United States; Recruiting

Sacramento, California, United States; Recruiting

San Diego, California, United States; Recruiting

San Jose, California, United States; Recruiting

San Ramon, California, United States; Recruiting

Santa Clarita, California, United States; Recruiting

Tustin, California, United States; Recruiting

Upland, California, United States; Recruiting

Arvada, Colorado, United States; Recruiting

Westminster, Colorado, United States; Recruiting

Wheat Ridge, Colorado, United States; Recruiting

Lewes, Delaware, United States; Recruiting

Boynton Beach, Florida, United States; Recruiting

Brandon, Florida, United States; Recruiting

Clearwater, Florida, United States; Recruiting

Coral Gables, Florida, United States; Recruiting

Coral Springs, Florida, United States; Recruiting

Daytona Beach, Florida, United States; Recruiting

Deland, Florida, United States; Recruiting

Doral, Florida, United States; Completed

Edgewater, Florida, United States; Recruiting

Fort Lauderdale, Florida, United States; Recruiting

Fort Meyers, Florida, United States; Recruiting

Fort Myers, Florida, United States; Recruiting

Hialeah, Florida, United States; Recruiting

Hollywood, Florida, United States; Recruiting

Homestead, Florida, United States; Recruiting

Jacksonville, Florida, United States; Recruiting

Jupiter, Florida, United States; Recruiting

Miami, Florida, United States; Recruiting

North Bay Village, Florida, United States; Recruiting

Orlando, Florida, United States; Recruiting

Pembroke Pines, Florida, United States; Recruiting

Pinellas Park, Florida, United States; Recruiting

Plant City, Florida, United States; Recruiting

Port Charlotte, Florida, United States; Recruiting

Sanford, Florida, United States; Recruiting

Tallahassee, Florida, United States; Completed

Tampa, Florida, United States; Recruiting

Winter Haven, Florida, United States; Recruiting

Winter Park, Florida, United States; Not yet recruiting

Atlanta, Georgia, United States; Recruiting

Augusta, Georgia, United States; Recruiting

Columbus, Georgia, United States; Recruiting

Dunwoody, Georgia, United States; Recruiting

Fort Valley, Georgia, United States; Recruiting

Marietta, Georgia, United States; Recruiting

Newnan, Georgia, United States; Recruiting

Norcross, Georgia, United States; Recruiting

Roswell, Georgia, United States; Recruiting

Savannah, Georgia, United States; Completed

Suwanee, Georgia, United States; Recruiting

Honolulu, Hawaii, United States; Recruiting

Meridian, Idaho, United States; Recruiting

Gurnee, Illinois, United States; Recruiting

Avon, Indiana, United States; Active, not recruiting

Brownsburg, Indiana, United States; Recruiting

Newburgh, Indiana, United States; Recruiting

Augusta, Kansas, United States; Recruiting

Wichita, Kansas, United States; Recruiting

Crestview Hills, Kentucky, United States; Recruiting

Elizabethtown, Kentucky, United States; Recruiting

Lexington, Kentucky, United States; Recruiting

Louisville, Kentucky, United States; Recruiting

Owensboro, Kentucky, United States; Recruiting

Paducah, Kentucky, United States; Recruiting

Baker, Louisiana, United States; Recruiting

Lafayette, Louisiana, United States; Recruiting

Mandeville, Louisiana, United States; Recruiting

Metairie, Louisiana, United States; Recruiting

Biddeford, Maine, United States; Recruiting

Columbia, Maryland, United States; Recruiting

Frederick, Maryland, United States; Recruiting

Oxon Hill, Maryland, United States; Recruiting

Brockton, Massachusetts, United States; Completed

Fall River, Massachusetts, United States; Recruiting

Framingham, Massachusetts, United States; Not yet recruiting

Buckley, Michigan, United States; Recruiting

Detroit, Michigan, United States; Not yet recruiting

Kalamazoo, Michigan, United States; Recruiting

Biloxi, Mississippi, United States; Recruiting

Olive Branch, Mississippi, United States; Recruiting

Hazelwood, Missouri, United States; Recruiting

Washington, Missouri, United States; Recruiting

Billings, Montana, United States; Recruiting

Missoula, Montana, United States; Recruiting

Bellevue, Nebraska, United States; Recruiting

Lincoln, Nebraska, United States; Recruiting

Omaha, Nebraska, United States; Recruiting

Las Vegas, Nevada, United States; Recruiting

Reno, Nevada, United States; Recruiting

Lodi, New Jersey, United States; Completed

Teaneck, New Jersey, United States; Completed

Albuquerque, New Mexico, United States; Recruiting

Brooklyn, New York, United States; Recruiting

Endwell, New York, United States; Recruiting

Manhasset, New York, United States; Active, not recruiting

Columbiana, North Carolina, United States; Recruiting

Greensboro, North Carolina, United States; Recruiting

Greenville, North Carolina, United States; Recruiting

Hickory, North Carolina, United States; Recruiting

Raleigh, North Carolina, United States; Completed

Salisbury, North Carolina, United States; Recruiting

Wilmington, North Carolina, United States; Recruiting

Fargo, North Dakota, United States; Recruiting

Chagrin Falls, Ohio, United States; Completed

Cincinnati, Ohio, United States; Recruiting

Cleveland, Ohio, United States; Recruiting

Lyndhurst, Ohio, United States; Recruiting

Mentor, Ohio, United States; Completed

Perrysburg, Ohio, United States; Recruiting

Toledo, Ohio, United States; Recruiting

Wadsworth, Ohio, United States; Recruiting

Willoughby Hills, Ohio, United States; Completed

Oklahoma City, Oklahoma, United States; Recruiting

Tulsa, Oklahoma, United States; Recruiting

Portland, Oregon, United States; Recruiting

Altoona, Pennsylvania, United States; Recruiting

Duncansville, Pennsylvania, United States; Recruiting

Harleysville, Pennsylvania, United States; Recruiting

Lansdale, Pennsylvania, United States; Recruiting

McMurray, Pennsylvania, United States; Recruiting

Media, Pennsylvania, United States; Recruiting

Philadelphia, Pennsylvania, United States; Completed

Pittsburgh, Pennsylvania, United States; Recruiting

Uniontown, Pennsylvania, United States; Recruiting

Wyomissing, Pennsylvania, United States; Recruiting

Charleston, South Carolina, United States; Recruiting

Columbia, South Carolina, United States; Recruiting

Greer, South Carolina, United States; Recruiting

Mount Pleasant, South Carolina, United States; Recruiting

Rapid City, South Dakota, United States; Recruiting

Bristol, Tennessee, United States; Recruiting

Collierville, Tennessee, United States; Recruiting

Jackson, Tennessee, United States; Recruiting

Memphis, Tennessee, United States; Recruiting

Arlington, Texas, United States; Recruiting

Austin, Texas, United States; Recruiting

Bellaire, Texas, United States; Recruiting

Carrollton, Texas, United States; Recruiting

Corpus Christi, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

Humble, Texas, United States; Recruiting

Plano, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Sugar Land, Texas, United States; Completed

The Woodlands, Texas, United States; Completed

Bountiful, Utah, United States; Recruiting

Salt Lake City City, Utah, United States; Recruiting

West Jordan, Utah, United States; Recruiting

Alexandria, Virginia, United States; Recruiting

Arlington, Virginia, United States; Recruiting

Burke, Virginia, United States; Recruiting

Charlottesville, Virginia, United States; Recruiting

Danville, Virginia, United States; Recruiting

Midlothian, Virginia, United States; Recruiting

Newport News, Virginia, United States; Recruiting

Norfolk, Virginia, United States; Recruiting

Richmond, Virginia, United States; Recruiting

Sterling, Virginia, United States; Recruiting

Spokane, Washington, United States; Recruiting

Clarksburg, West Virginia, United States; Completed

Milwaukee, Wisconsin, United States; Completed

Additional Information

Starting date: May 2014
Last updated: July 30, 2015

Page last updated: August 23, 2015

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