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GoutPhase 2NCT02128490

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

A Phase 2 study testing Febuxostat IR, Febuxostat XR and Colchicine in people with Gout and Moderate Renal Impairment, run by Takeda at 89 sites in United States.

Completed

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

Official record
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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 gout participants with moderate renal impairment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gout, Moderate Renal Impairment
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
189 participants
Where
89 sitesUnited States
Study dates
May 2014to Oct 2015
Phase
Phase 2
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) [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.
  • 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 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.
  • 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.
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  • 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 either a myocardial infarction (MI), stroke, hospitalized unstable angina, cardiac or cerebrovascular revascularization procedure or hospitalized transient ischemic attack (TIA).
  • 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.
  • 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

89 sites in 1 country.

89 sites in 1 country

United States89 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bellaire, Texas

  • Study site

    Bellflower, California

  • Study site

    Birmingham, Alabama

  • Study site

    Bountiful, Utah

  • Study site

    Brownsburg, Indiana

  • Study site

    Clarksville, Tennessee

  • Study site

    Clearwater, Florida

  • Study site

    Columbia, South Carolina

  • Study site

    Columbiana, North Carolina

  • Study site

    Coral Gables, Florida

  • Study site

    Coral Springs, Florida

  • 3rd Coast Research Associates

    Corpus Christi, Texas, 78413

  • Study site

    Corpus Christi, Texas

  • Study site

    Detroit, Michigan

  • Study site

    Dunwoody, Georgia

  • Study site

    East Point, Georgia

  • Riverside Clinical Research

    Edgewater, Florida, 32141

  • Study site

    Edgewater, Florida

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Escondido, California

  • Study site

    Fall River, Massachusetts

  • Study site

    Fargo, North Dakota

  • Study site

    Franklin, Ohio

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Harbor City, California

  • Study site

    Hazelwood, Missouri

  • Study site

    Hialeah, Florida

  • East West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Study site

    Honolulu, Hawaii

  • Study site

    Huntington Park, California

  • Study site

    Irvine, California

  • Study site

    Kalamazoo, Michigan

  • Study site

    Knoxville, Tennessee

  • Study site

    Las Vegas, Nevada

  • Central Kentucy Reseach Associates

    Lexington, Kentucky, 40509

  • Study site

    Lexington, Kentucky

  • Benny Green MD PA Family Practice

    Little Rock, Arkansas, 72223

  • Study site

    Little Rock, Arkansas

  • Study site

    Lomita, California

  • Long Beach Center for Clinical Research

    Long Beach, California, 90807

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Mandeville, Louisiana

  • Study site

    Manhattan, Kansas

  • Remesh C Gupta MD

    Memphis, Tennessee, 38119

  • Study site

    Memphis, Tennessee

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Miami Beach, Florida

  • Study site

    Miami Lakes, Florida

  • Brigid Freyne MD

    Murrieta, California, 92563

  • Study site

    Murrieta, California

  • Study site

    Muscle Shoals, Alabama

  • Study site

    Nassau Bay, Texas

  • Study site

    Newport News, Virginia

  • Study site

    Norfolk, Virginia

  • COR Clinical Research LLC

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Old Point Station, South Carolina

  • Study site

    Orange, California

  • Study site

    Orlando, Florida

  • Study site

    Paducah, Kentucky

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Plano, Texas

  • Study site

    Plantation, Florida

  • Study site

    Port Charlotte, Florida

  • Study site

    Portland, Oregon

  • Study site

    Rancho Cucamonga, California

  • Study site

    Redondo Beach, California

  • Study site

    Richmond, Virginia

  • Study site

    Sacramento, California

  • Study site

    Saint Cloud, Florida

  • Study site

    Salisbury, North Carolina

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Briggs Clinical Research LLC

    San Antonio, Texas, 78224

  • Study site

    San Antonio, Texas

  • Study site

    San Jose, California

  • Study site

    San Ramon, California

  • Study site

    Suwanee, Georgia

  • Study site

    Vero Beach, Florida

  • Study site

    Virginia Beach, Virginia

  • Study site

    Washington, Missouri

  • Study site

    Wichita, Kansas

  • Study site

    Wilmington, North Carolina

Other trials in United States

About this study

Official title: 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.

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 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.

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

    Febuxostat over-encapsulated capsules

  • Febuxostat placeboDrug

    Febuxostat IR and XR placebo-matching capsules

  • ColchicineDrug

    Colchicine tablets

  • NaproxenDrug

    Naproxen tablets

  • LansoprazoleDrug

    Lansoprazole capsules

Study groups in NCT02128490
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 other day, or, 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 other day, or, 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 other day, or, 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 other day, or, 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 other day, or, 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 posted1 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2015
  4. Study completionOct 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02128490
Sponsor's protocol ID
FEB-XR_201
Other IDs
U1111-1152-3942
Status last verified
Sep 2016
First submitted
29 Apr 2014
Last updated
3 Nov 2016
Data monitoring committee
Yes

Publications

  • Gunawardhana L, Becker MA, Whelton A, Hunt B, Castillo M, Saag K. Efficacy and safety of febuxostat extended release and immediate release in patients with gout and moderate renal impairment: phase II placebo-controlled study. Arthritis Res Ther. 2018 May 30;20(1):99. doi: 10.1186/s13075-018-1593-0.

    PubMed 29848361

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Febuxostat IR, Febuxostat XR and Colchicine in people with Gout and Moderate Renal Impairment, run by Takeda at 89 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 17 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 89 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 NCT02128490, 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; AzTrials last refreshed its copy on 8 Nov 2026.

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