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Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (LIGHT)

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ClinicalTrials.gov Identifier: NCT01508702
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Brief Summary:
This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.

Condition or disease Intervention/treatment Phase
Gout Drug: lesinurad Drug: Placebo Phase 3

Detailed Description:
Allopurinol is the standard of care for the treatment of gout. In practice, approximately 20% of patients report side effects with allopurinol and 5% discontinue allopurinol due to side effects. Allopurinol can cause gastrointestinal intolerance, such as nausea and diarrhea, which appears to be dosedependent. Rash develops in about 2% of patients treated with allopurinol, and in about 20% of patients treated with allopurinol and ampicillin or amoxicillin. Allopurinol hypersensitivity syndrome remains a major concern among physicians. Mortality has been estimated to be up to nearly one quarter of AHS cases, with multiorgan system disease including hepatocellular changes and renal failure being a serious concern. Allopurinol is also relatively contraindicated for use in combination with 6-mercaptopurine and azathioprine, for which 1/4 to 1/3 lower doses must be given in order to avoid hematologic toxicity. Febuxostat, in clinical trials, has shown a similar AE profile to allopurinol. Liver function abnormalities, nausea, arthralgia and rash were the most commonly reported AEs. In postmarketing experience, Stevens Johnson Syndrome and hypersensitivity rashes have been reported (febuxostat prescribing information). Withdrawals due to AEs were similar in frequency to allopurinol as well. Relative contraindications in combination with 6-mercaptopurine and azathioprine are similar to allopurinol as well. Lesinurad may be an important therapeutic option for patients who either cannot tolerate or who have a contraindication to the use of allopurinol or febuxostat.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled Study to Assess the Efficacy and Safety of Lesinurad Monotherapy Compared to Placebo in Subjects With Gout and an Intolerance or Contraindication to a Xanthine Oxidase Inhibitor
Study Start Date : January 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: lesinurad 400 mg Drug: lesinurad
Tablets, 400 mg QD

Placebo Comparator: placebo Drug: Placebo
Tablets, Placebo QD




Primary Outcome Measures :
  1. Number of Subjects With an sUA Level That is < 6.0 mg/dL [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
  • Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
  • Subject has an sUA level ≥ 6.5 mg/dL at the Screening and Day -7 Visits.
  • Subject must be able to take gout flare prophylaxis with colchicine or NSAID (including Cox-2 selective NSAID) ± PPI.
  • Subject has a history (either by medical record or subject interview) of intolerance or a contraindication to either allopurinol or febuxostat.
  • Body mass index (BMI) < 45 kg/m2

Exclusion Criteria:

  • Subject who is taking any other approved urate-lowering medication that is indicated for the treatment of gout at the Screening Visit.
  • Subject with a documented history or suspicion of kidney stones.
  • Subject who is pregnant or breastfeeding.
  • Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
  • Subject with a history or suspicion of drug abuse within the past 5 years.
  • Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment.
  • Subject with a known or suspected human immunodeficiency virus (HIV) infection.
  • Subject with a positive test for active hepatitis B or hepatitis C infection.
  • Subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.
  • Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.
  • Subject with uncontrolled hypertension.
  • Subject with an estimated creatinine clearance < 30 mL/min.
  • Subject with active peptic ulcer disease requiring treatment.
  • Subject with active liver disease, or hepatic dysfunction.
  • Subject receiving chronic treatment with more than 325 mg salicylates per day.
  • Subject taking valpromide, progabide, or valproic acid.
  • Subject who has received an investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit.
  • Subject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

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): NCT01508702


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Locations
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United States, Alabama
Birmingham, Alabama, United States, 35211
Birmingham, Alabama, United States, 35294
United States, Arizona
Glendale, Arizona, United States, 85308
Phoenix, Arizona, United States, 85050
Tucson, Arizona, United States, 85724
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, California
Anaheim, California, United States, 92805
Carmichael, California, United States, 95608
Covina, California, United States, 91723
Huntington Park, California, United States, 90255
Irvine, California, United States, 92618
United States, Colorado
Colorado Springs, Colorado, United States, 80922
Denver, Colorado, United States, 80220
Denver, Colorado, United States, 80230
Englewood, Colorado, United States, 80113
United States, Connecticut
Milford, Connecticut, United States, 06460
Trumbull, Connecticut, United States, 06611
United States, Florida
Boynton Beach, Florida, United States, 33472
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33135
Miami, Florida, United States, 33143
Plant City, Florida, United States, 33563
Port Orange, Florida, United States, 32127
Tampa, Florida, United States, 33607
Winter Haven, Florida, United States, 33880
United States, Georgia
Newman, Georgia, United States, 30265
United States, Hawaii
Honolulu, Hawaii, United States, 96814
United States, Idaho
Meridian, Idaho, United States, 83646
United States, Illinois
Chicago, Illinois, United States, 60624
United States, Kentucky
Elizabethtown, Kentucky, United States, 42701
Lexington, Kentucky, United States, 40504
Louisville, Kentucky, United States, 40213
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Michigan
South Traverse, Michigan, United States, 49684
United States, Mississippi
Jackson, Mississippi, United States, 39202
Olive Branch, Mississippi, United States, 38654
United States, Missouri
Southfield, Missouri, United States, 48034
Washington, Missouri, United States, 63090
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
Albuquerque, New Mexico, United States, 87106
United States, New York
Brooklyn, New York, United States, 11201
Hartsdale, New York, United States, 10530
New Windsor, New York, United States, 12553
New York, New York, United States, 10016
United States, North Carolina
Hickory, North Carolina, United States, 28602
Raleigh, North Carolina, United States, 27612
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Cincinnati, Ohio, United States, 45224
Cincinnati, Ohio, United States, 45242
Middleburgh Heights, Ohio, United States, 44130
Perrysburgh, Ohio, United States, 43551
Willoughby Hills, Ohio, United States, 44904
United States, Oklahoma
Norman, Oklahoma, United States, 73069
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
Lancaster, Pennsylvania, United States, 17601
Lansdale, Pennsylvania, United States, 19446
Pittsburgh, Pennsylvania, United States, 15237
Reading, Pennsylvania, United States, 19606
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Myrtle Beach, South Carolina, United States, 29588
Rock Hill, South Carolina, United States, 29732
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Brentwood, Tennessee, United States, 37027
Spring Hill, Tennessee, United States, 37174
United States, Texas
Dallas, Texas, United States, 75235
Houston, Texas, United States, 77098
San Antonio, Texas, United States, 78229
Victoria, Texas, United States, 77901
United States, Utah
South Bountiful, Utah, United States, 84010
West Jordon, Utah, United States, 84088
West Layton, Utah, United States, 84041
United States, Virginia
Chesapeake, Virginia, United States, 23320
Richmond, Virginia, United States, 23235
Suffolk, Virginia, United States, 23435
United States, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99208
United States, West Virginia
Morgantown, West Virginia, United States, 26505
Australia, Queensland
Butterfield, Queensland, Australia, 4029
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia
Tasmania, Australia, 7000
Belgium
Anderlecht, Brussels, Belgium, 1070
Genk, Limburg, Belgium, 3600
Gozee, Belgium, 6534
Kortrijk, Belgium, 8500
Yvoir, Belgium, 5530
Canada, British Columbia
Coquitiam, British Columbia, Canada, V3K 3P4
Coquitlam, British Columbia, Canada, V3K 3P4
Victoria, British Columbia, Canada, V8V 3N7
Canada, Ontario
London, Ontario, Canada, N6A 5R8
Mississauga, Ontario, Canada, L5M 2V8
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Rimouski, Quebec, Canada, G5L 8W1
Canada
Quebec, Canada, G1V 3M7
Germany
Dresden, Saxony, Germany, 01307
Leipzig, Saxony, Germany, 04109
Dresden, Germany, 01069
New Zealand
Tauranga, Bay of Plenty, New Zealand, 3143
Auckland, New Zealand, 1010
Auckland, New Zealand, 1023
South Africa
Durban, South Africa, 4092
Pretoria, South Africa, 0002
Rondebosch, South Africa, 7700
Stellenbosch, South Africa, 7600
Thabazimbi, South Africa, 0380
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: Chris Storgard, MD Ardea Biosciences, Inc.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01508702     History of Changes
Other Study ID Numbers: RDEA594-303
2011-003756-39 ( EudraCT Number )
First Posted: January 12, 2012    Key Record Dates
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016
Last Verified: July 2015
Keywords provided by Ardea Biosciences, Inc.:
Gout
Additional relevant MeSH terms:
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Gout
Gout Suppressants
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Lesinurad
Antirheumatic Agents
Uricosuric Agents
Renal Agents