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

September 15, 2016 updated by: Takeda

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 with moderate renal impairment. 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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
      • Little Rock, Arkansas, United States, 72223
        • Benny Green MD PA Family Practice
    • California
      • 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, California, United States, 90807
        • Long Beach Center For Clinical Research
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Murrieta, California, United States
      • Murrieta, California, United States, 92563
        • Brigid Freyne MD
      • 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
    • Florida
      • Clearwater, Florida, United States
      • Coral Gables, Florida, United States
      • Coral Springs, Florida, United States
      • Edgewater, Florida, United States
      • Edgewater, Florida, United States, 32141
        • Riverside Clinical Research
      • 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
    • Georgia
      • Atlanta, Georgia, United States
      • Dunwoody, Georgia, United States
      • East Point, Georgia, United States
      • Suwanee, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
      • Honolulu, Hawaii, United States, 96814
        • East West Medical Research Institute
    • Indiana
      • Brownsburg, Indiana, United States
    • Kansas
      • Manhattan, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Elizabethtown, Kentucky, United States
      • Lexington, Kentucky, United States
      • Lexington, Kentucky, United States, 40509
        • Central Kentucy Reseach Associates
      • Paducah, Kentucky, United States
    • Louisiana
      • Mandeville, Louisiana, United States
      • Metairie, Louisiana, United States
    • Massachusetts
      • Fall River, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Kalamazoo, Michigan, United States
    • Missouri
      • Hazelwood, Missouri, United States
      • Washington, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • North Carolina
      • Columbiana, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Wilmington, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Franklin, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States, 73103
        • COR Clinical Research LLC
    • Oregon
      • Portland, Oregon, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Greer, South Carolina, United States
      • Indian Land, South Carolina, United States
    • Tennessee
      • Clarksville, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Memphis, Tennessee, United States
      • Memphis, Tennessee, United States, 38119
        • Remesh C Gupta MD
    • Texas
      • Austin, Texas, United States
      • Bellaire, Texas, United States
      • Corpus Christi, Texas, United States
      • Corpus Christi, Texas, United States, 78413
        • 3rd Coast Research Associates
      • Nassau Bay, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • San Antonio, Texas, United States, 78224
        • Briggs Clinical Research LLC
    • Utah
      • Bountiful, Utah, United States
    • Virginia
      • Newport News, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Virginia Beach, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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) [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:

  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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Drug: Lansoprazole
Lansoprazole capsules
Drug: Febuxostat IR
Febuxostat IR over-encapsulated tablets
Other Names:
  • Uloric
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
Active Comparator: 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.
Drug: Lansoprazole
Lansoprazole capsules
Drug: Febuxostat IR
Febuxostat IR over-encapsulated tablets
Other Names:
  • Uloric
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
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 other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
Drug: Lansoprazole
Lansoprazole capsules
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
Drug: Febuxostat XR
Febuxostat over-encapsulated capsules
Experimental: 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.
Drug: Lansoprazole
Lansoprazole capsules
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
Drug: Febuxostat XR
Febuxostat over-encapsulated capsules
Placebo Comparator: 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.
Drug: Lansoprazole
Lansoprazole capsules
Drug: Colchicine
Colchicine tablets
Drug: Naproxen
Naproxen tablets
Drug: Febuxostat placebo
Febuxostat IR and XR placebo-matching capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3
Time Frame: Month 3
Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to Month 3
Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3
Time Frame: Month 3
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FEB-XR_201
  • U1111-1152-3942 (Other Identifier: World Health Organization)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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