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Trial record 1 of 1 for:    FEB-XR_301
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Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02139046
First Posted: May 15, 2014
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
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.

Condition Intervention Phase
Gout Drug: Febuxostat IR Drug: Febuxostat XR Drug: Febuxostat placebo Drug: Colchicine Drug: Naproxen Drug: Lansoprazole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 [ Time Frame: Month 3 ]

Secondary Outcome Measures:
  • Percentage of Participants With at Least One Gout Flare Requiring Treatment [ Time Frame: Baseline to Month 3 ]

    A participant was considered to have a gout flare if the following criteria were met:

    Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare.


  • Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3 [ Time Frame: Month 3 ]

Enrollment: 1790
Study Start Date: April 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Febuxostat IR
Febuxostat IR over-encapsulated tablets
Other Name: Uloric
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
Drug: Lansoprazole
Lansoprazole capsules
Active Comparator: 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.
Drug: Febuxostat IR
Febuxostat IR over-encapsulated tablets
Other Name: Uloric
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
Drug: Lansoprazole
Lansoprazole capsules
Experimental: 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.
Drug: Febuxostat XR
Febuxostat XR over-encapsulated capsules
Other Name: Uloric
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
Drug: Lansoprazole
Lansoprazole capsules
Experimental: 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.
Drug: Febuxostat XR
Febuxostat XR over-encapsulated capsules
Other Name: Uloric
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
Drug: Lansoprazole
Lansoprazole capsules
Placebo Comparator: 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.
Drug: Febuxostat placebo
Febuxostat placebo-matching capsules
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
Drug: Lansoprazole
Lansoprazole capsules

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139046


  Show 192 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02139046     History of Changes
Other Study ID Numbers: FEB-XR_301
U1111-1152-4040 ( Other Identifier: World Health Organization )
First Submitted: May 13, 2014
First Posted: May 15, 2014
Results First Submitted: September 15, 2016
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016
Last Verified: September 2016

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Naproxen
Colchicine
Febuxostat
Lansoprazole
Dexlansoprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors