Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.

NCT02187029

Last updated date
Study Location
MRA Clinical Research, LLC
Miami, Florida, 33143, United States
Contact
1-800-718-1021

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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gout
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of acute Arthritis of Primary Gout.

- Subjects taking urate lowering therapy at the time of screening must be willing to discontinue their prior urate lowering therapy from the time of Screening Visit 1 until completion of the study period Day 16.

- Subjects taking urate lowering therapy at the time of screening must have a serum urate level of >= 8.0 mg/dL at time of the second screening visit.

- Subjects NOT taking urate lowering therapy at the time of screening must have a serum urate level of >= 8.0 mg/dL at both screening visits 1 and 2.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Positive medical history or current evidence of medical or psychiatric
condition/disease, or ECG or laboratory abnormality that may increase the risk
associated with study participation or investigational product administration or may
interfere with the interpretation of study results and, in the judgment of the
Investigator, would make the subject inappropriate for entry into this study.


- Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline,
National Kidney Foundation)12; with GFR < 60 mL/min/1.73m2 calculated by the
Cockcroft-Gault equation.


- Subjects with current tophaceous gout.


- Gout flare that has not resolved for at least 2 weeks prior to randomization.

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GoutEfficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.
NCT02187029
  1. Miami, Florida
  2. South Miami, Florida
  3. Overland Park, Kansas
  4. Overland Park, Kansas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.
Official Title  ICMJE A Randomized, Double Blind, Third Party Open, Placebo Controlled Multi-center Study Of Efficacy, Safety And Tolerability Of Pf-06743649 In Gout Subjects
Brief Summary The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid in subjects suffering from gout following 14 days of dosing, as well as assessing safety and tolerability.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gout
Intervention  ICMJE
  • Drug: PF-06743649
    Daily dosing (dose level 1) tablet for 14 days
  • Other: Placebo
    Daily dosing (tablet) for 14 days
  • Drug: PF-06743649
    Daily dosing (dose level 2) tablet(s) for 14 days
  • Other: Placebo
    Daily dosing (tablets) for 14 days
Study Arms  ICMJE
  • Experimental: PF-06743649 dose level 1 (Cohort 1)
    Intervention: Drug: PF-06743649
  • Placebo Comparator: Placebo for PF-06743649 (Cohort 1)
    Intervention: Other: Placebo
  • Experimental: PF-06743649 dose level 2 (Cohort 2)
    Intervention: Drug: PF-06743649
  • Placebo Comparator: Placebo for PF-06743649 (Cohort 2)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 23, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2014)
27
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of acute Arthritis of Primary Gout.
  • Subjects taking urate lowering therapy at the time of screening must be willing to discontinue their prior urate lowering therapy from the time of Screening Visit 1 until completion of the study period Day 16.
  • Subjects taking urate lowering therapy at the time of screening must have a serum urate level of >= 8.0 mg/dL at time of the second screening visit.
  • Subjects NOT taking urate lowering therapy at the time of screening must have a serum urate level of >= 8.0 mg/dL at both screening visits 1 and 2.

Exclusion Criteria:

  • Positive medical history or current evidence of medical or psychiatric condition/disease, or ECG or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
  • Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline, National Kidney Foundation)12; with GFR < 60 mL/min/1.73m2 calculated by the Cockcroft-Gault equation.
  • Subjects with current tophaceous gout.
  • Gout flare that has not resolved for at least 2 weeks prior to randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02187029
Other Study ID Numbers  ICMJE B7911002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP