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GoutPhase 3NCT02139046

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

A Phase 3 study testing Febuxostat IR, Febuxostat XR and Colchicine in people with Gout, run by Takeda at 192 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gout
What is being tested?
Febuxostat IR, Febuxostat XR and Colchicine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,790 participants
Where
192 sitesUnited States
Study dates
Apr 2014to Nov 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • 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.
  • 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:
  • A tophus proven to contain urate crystals by chemical or polarized light microscopic means, AND/OR;
  • Characteristic urate crystals in the joint fluid, AND/OR;
  • History of at least 6 of the following clinical, laboratory, and x-ray phenomena:
Show all 12Show fewer
  • 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.
  • Is male or female at least 18 years of age, inclusive.
  • 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.
  • Have a serum urate (sUA) level ≥8.0 mg/dL at the Day -4 Visit or at the retest visit.
  • 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.
  • Has at least one gout flare within 12 months prior to Screening visit.

Who cannot join

  • Has received any investigational compound within 30 days prior to Screening.
  • 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.
  • Is breastfeeding or pregnant.
  • Has secondary hyperuricemia (eg, due to myeloproliferative disorder).
  • Has a history of xanthinuria.
  • Has received ULT (ie, allopurinol, probenecid, etc.) within 20 days prior to Day 1/Randomization Visit.
Show all 18Show fewer
  • 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.
  • Has active peptic ulcer disease.
  • Has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the Screening Visit.
  • Has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values >2 x the upper limit of normal (ULN).
  • Has rheumatoid arthritis which requires treatment.
  • Has a significant medical condition and/or conditions that would interfere with the treatment, safety, or compliance with the protocol.
  • 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.
  • 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.
  • Participant consumes >14 alcoholic beverages/week. Has a history of alcoholism or illicit drug abuse within 5 years.
  • Has participated in another investigational study within the 30 days prior to the Screening Visit.
  • Has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
  • Is required to take excluded medications.

Trial locations and contacts

192 sites in 1 country.

192 sites in 1 country

United States192 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alexandria, Virginia

  • Study site

    Altoona, Pennsylvania

  • Study site

    Arlington, Texas

  • Study site

    Arlington, Virginia

  • Study site

    Arvada, Colorado

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Augusta, Kansas

  • Study site

    Austin, Texas

  • Study site

    Avon, Indiana

  • Study site

    Baker, Louisiana

  • Study site

    Bellaire, Texas

  • Study site

    Bellevue, Nebraska

  • Study site

    Bellflower, California

  • Study site

    Biddeford, Maine

  • Study site

    Billings, Montana

  • Study site

    Biloxi, Mississippi

  • Study site

    Binghamton, Alabama

  • Study site

    Birmingham, Alabama

  • Study site

    Bountiful, Utah

  • Study site

    Boynton Beach, Florida

  • Study site

    Brandon, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Brockton, Massachusetts

  • Study site

    Brooklyn, New York

  • Study site

    Brownsburg, Indiana

  • Study site

    Buckley, Michigan

  • Study site

    Burke, Virginia

  • Study site

    Carmichael, California

  • Study site

    Carrollton, Texas

  • Study site

    Chagrin Falls, Ohio

  • Study site

    Charleston, South Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Cincinnati, Ohio

  • Study site

    Clarksburg, West Virginia

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Collierville, Tennessee

  • Study site

    Columbia, Maryland

  • Study site

    Columbia, South Carolina

  • Study site

    Columbiana, North Carolina

  • Study site

    Columbus, Georgia

  • Study site

    Coral Gables, Florida

  • Study site

    Coral Springs, Florida

  • Study site

    Corpus Christi, Texas

  • Study site

    Costa Mesa, California

  • Study site

    Covina, California

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Danville, Virginia

  • Study site

    Daytona Beach, Florida

  • Study site

    DeLand, Florida

  • Study site

    Detroit, Michigan

  • Study site

    Doral, Florida

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Dunwoody, Georgia

  • Study site

    Edgewater, Florida

  • Study site

    El Cajon, California

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Encinitas, California

  • Study site

    Encino, California

  • Study site

    Endwell, New York

  • Study site

    Escondido, California

  • Study site

    Fall River, Massachusetts

  • Study site

    Fargo, North Dakota

  • Study site

    Fayetteville, Arkansas

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Meyers, Florida

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Valley, Georgia

  • Study site

    Frederick, Maryland

  • Study site

    Gilbert, Arizona

  • Study site

    Glendale, Arizona

  • Study site

    Gold River, California

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Gurnee, Illinois

  • Study site

    Harleysville, Pennsylvania

  • Study site

    Hazelwood, Missouri

  • Study site

    Hialeah, Florida

  • Study site

    Hickory, North Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Homestead, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Humble, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Irvine, California

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jupiter, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Lafayette, Louisiana

  • Study site

    Lancaster, California

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Las Vegas, Nevada

  • Study site

    Lewes, Delaware

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Lodi, New Jersey

  • Study site

    Lomita, California

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lyndhurst, Ohio

  • Study site

    Mandeville, Louisiana

  • Study site

    Manhasset, New York

  • Study site

    Marietta, Georgia

  • Study site

    McMurray, Pennsylvania

  • Study site

    Media, Pennsylvania

  • Study site

    Memphis, Tennessee

  • Study site

    Mentor, Ohio

  • Study site

    Meridian, Idaho

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Midlothian, Virginia

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Missoula, Montana

  • Study site

    Monterey Park, California

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Murrieta, California

  • Study site

    Newburgh, Indiana

  • Study site

    Newnan, Georgia

  • Study site

    Newport News, Virginia

  • Study site

    Norcross, Georgia

  • Study site

    Norfolk, Virginia

  • Study site

    North Bay Village, Florida

  • Study site

    North Hollywood, California

  • Study site

    Norwalk, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Owensboro, Kentucky

  • Study site

    Oxon Hill, Maryland

  • Study site

    Paducah, Kentucky

  • Study site

    Paramount, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Perrysburg, Ohio

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pinellas Park, Florida

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Plant City, Florida

  • Study site

    Port Charlotte, Florida

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Rancho Cucamonga, California

  • Study site

    Rapid City, South Dakota

  • Study site

    Reno, Nevada

  • Study site

    Richmond, Virginia

  • Study site

    Riverside, California

  • Study site

    Roseville, California

  • Study site

    Roswell, Georgia

  • Study site

    Sacramento, California

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Jose, California

  • Study site

    San Ramon, California

  • Study site

    Sanford, Florida

  • Study site

    Santa Clarita, California

  • Study site

    Savannah, Georgia

  • Study site

    Searcy, Arkansas

  • Study site

    Spokane, Washington

  • Study site

    Sterling, Virginia

  • Study site

    Sugar Land, Texas

  • Study site

    Suwanee, Georgia

  • Study site

    Tallahassee, Florida

  • Study site

    Tampa, Florida

  • Study site

    Teaneck, New Jersey

  • Study site

    The Woodlands, Texas

  • Study site

    Toledo, Ohio

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tustin, California

  • Study site

    Uniontown, Pennsylvania

  • Study site

    Upland, California

  • Study site

    Wadsworth, Ohio

  • Study site

    Washington, Missouri

  • Study site

    West Jordan, Utah

  • Study site

    Westminster, Colorado

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Wichita, Kansas

  • Study site

    Willoughby Hills, Ohio

  • Study site

    Wilmington, North Carolina

  • Study site

    Winter Haven, Florida

  • Study site

    Wyomissing, Pennsylvania

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Gout
Being tested
Febuxostat IR, Febuxostat XR, Febuxostat placebo, Colchicine, Naproxen
Keywords
Drug therapy
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Febuxostat IRDrug

    Also called Uloric

    Febuxostat IR over-encapsulated tablets

  • Febuxostat XRDrug

    Also called Uloric

    Febuxostat XR over-encapsulated capsules

  • Febuxostat placeboDrug

    Febuxostat placebo-matching capsules

  • ColchicineDrug

    Colchicine tablets

  • NaproxenDrug

    Naproxen tablets

  • LansoprazoleDrug

    Lansoprazole capsules

Study groups in NCT02139046
Study groupRoleWhat they receive
Febuxostat IR 40 mgActive comparatorFebuxostat 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.
Receives: Drug: Febuxostat IR; Drug: Colchicine; Drug: Naproxen; Drug: Lansoprazole
Febuxostat IR 80 mgActive comparatorFebuxostat 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.
Receives: Drug: Febuxostat IR; Drug: Colchicine; Drug: Naproxen; Drug: Lansoprazole
Febuxostat XR 40 mgExperimentalFebuxostat 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.
Receives: Drug: Febuxostat XR; Drug: Colchicine; Drug: Naproxen; Drug: Lansoprazole
Febuxostat XR 80 mgExperimentalFebuxostat 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.
Receives: Drug: Febuxostat XR; Drug: Colchicine; Drug: Naproxen; Drug: Lansoprazole
PlaceboPlacebo comparatorFebuxostat 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.
Receives: Drug: Febuxostat placebo; Drug: Colchicine; Drug: Naproxen; Drug: Lansoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3

    Measured: Month 3

Secondary outcomes (2)

  1. Percentage of Participants With at Least One Gout Flare Requiring Treatment

    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.

    Measured: Baseline to Month 3

  2. Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,790 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02139046
Sponsor's protocol ID
FEB-XR_301
Other IDs
U1111-1152-4040
Status last verified
Sep 2016
First submitted
13 May 2014
Last updated
3 Nov 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30073793

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Febuxostat IR, Febuxostat XR and Colchicine in people with Gout, run by Takeda at 192 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3 (time frame: Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02139046, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.

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