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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
MRA Clinical Research, LLC
Miami, Florida, 33143 United States
Contact
1-800-718-1021
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 Cockcroft-Gault equation.

- Subjects with current tophaceous gout.

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

NCT02187029
Pfizer
Terminated
Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.

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NCT02187029
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Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.
A Randomized, Double Blind, Third Party Open, Placebo Controlled Multi-center Study Of Efficacy, Safety And Tolerability Of Pf-06743649 In Gout Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Gout
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
December 2014
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02187029
B7911002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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