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

NCT ID: NCT02187029

Last Updated: 2016-11-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Gout

Keywords

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Hyperuricemia gout serum uric acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-06743649 dose level 1 (Cohort 1)

Group Type EXPERIMENTAL

PF-06743649

Intervention Type DRUG

Daily dosing (dose level 1) tablet for 14 days

Placebo for PF-06743649 (Cohort 1)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Daily dosing (tablet) for 14 days

PF-06743649 dose level 2 (Cohort 2)

Group Type EXPERIMENTAL

PF-06743649

Intervention Type DRUG

Daily dosing (dose level 2) tablet(s) for 14 days

Placebo for PF-06743649 (Cohort 2)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Daily dosing (tablets) for 14 days

Interventions

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PF-06743649

Daily dosing (dose level 1) tablet for 14 days

Intervention Type DRUG

Placebo

Daily dosing (tablet) for 14 days

Intervention Type OTHER

PF-06743649

Daily dosing (dose level 2) tablet(s) for 14 days

Intervention Type DRUG

Placebo

Daily dosing (tablets) for 14 days

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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MRA Clinical Research, LLC

Miami, Florida, United States

Site Status

Miami Research Associates, Inc.

South Miami, Florida, United States

Site Status

Vince and Associates Clinical Research Inc.

Overland Park, Kansas, United States

Site Status

Vince and Associates Clinical Research, Inc.

Overland Park, Kansas, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7911002&StudyName=Efficacy%2C%20Safety%20And%20Tolerability%20Of%20PF-06743649%20In%20Gout%20Subjects.%0A

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Other Identifiers

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B7911002

Identifier Type: -

Identifier Source: org_study_id