PF-06372865 In Subjects With Chronic Low Back Pain

NCT ID: NCT02262754

Last Updated: 2017-01-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-08-31

Brief Summary

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PF-06372865 In Subjects With Chronic Low Back Pain

Detailed Description

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Conditions

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Chronic Low Back Pain

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-06372865

Daily BID dosing for 4 weeks

Group Type EXPERIMENTAL

PF-06372865

Intervention Type DRUG

Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks

Placebo

Daily BID dosing for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for PF-06372865 and placebo for naproxen daily

Naproxen

Daily BID dosing for 4 weeks

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

500 mg BID for 4 weeks

Interventions

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PF-06372865

Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks

Intervention Type DRUG

Placebo

Placebo for PF-06372865 and placebo for naproxen daily

Intervention Type DRUG

Naproxen

500 mg BID for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Agave Clinical Research, LLC

Mesa, Arizona, United States

Site Status

Arizona Research Center, Inc.

Phoenix, Arizona, United States

Site Status

Global Research

Anaheim, California, United States

Site Status

Neuro-Pain Medical Center

Fresno, California, United States

Site Status

Providence Clinical Research

North Hollywood, California, United States

Site Status

Elite Clinical Trials, Incorporate

Wildomar, California, United States

Site Status

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Site Status

Avail Clinical Research, LLC

DeLand, Florida, United States

Site Status

S&W Clinical Research

Fort Lauderdale, Florida, United States

Site Status

Florida Research Network, LLC

Gainesville, Florida, United States

Site Status

Broward Research Group

Hollywood, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Compass Research, LLC

Orlando, Florida, United States

Site Status

Pines Clinical Research Inc.

Pembroke Pines, Florida, United States

Site Status

Accord Clinical Research, LLC

Port Orange, Florida, United States

Site Status

Arthritis & Rheumatic Care Center

South Miami, Florida, United States

Site Status

Miami Research Associates

South Miami, Florida, United States

Site Status

Better Health Clinical Research, Inc.

Atlanta, Georgia, United States

Site Status

River Birch Research Alliance, LLC

Blue Ridge, Georgia, United States

Site Status

Family Medicine center

Columbus, Georgia, United States

Site Status

Columbus Regional Research Institute

Columbus, Georgia, United States

Site Status

Drug Studies America

Marietta, Georgia, United States

Site Status

Better Health Clinical Research, Inc./Georgia Pain & Spine Care, Inc.

Newnan, Georgia, United States

Site Status

Better Health Clinical Research, Inc.

Newnan, Georgia, United States

Site Status

Southeast Regional Research Group

Savannah, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

North Georgia Internal medicine

Woodstock, Georgia, United States

Site Status

Chicago Anesthesia Associates

Chicago, Illinois, United States

Site Status

Centex Studies, Inc

Lake Charles, Louisiana, United States

Site Status

Boston Clinical Trials

Boston, Massachusetts, United States

Site Status

ActivMed Practices & Research, Inc.

Methuen, Massachusetts, United States

Site Status

CRC of Jackson

Jackson, Mississippi, United States

Site Status

Physician's Surgery Center

Jackson, Mississippi, United States

Site Status

Drug Trials America

Hartsdale, New York, United States

Site Status

AAIR Research Center

Rochester, New York, United States

Site Status

Wake Internal Medicine Consultants, Inc.

Raleigh, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Summit Research Network (Oregon), Inc.

Portland, Oregon, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Omega Medical Research

Warwick, Rhode Island, United States

Site Status

Clinical Trial Network

Houston, Texas, United States

Site Status

Lee Medical Associates, PA

San Antonio, Texas, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

National Clinical Research - Norfolk, Inc.

Norfolk, Virginia, United States

Site Status

Summit Research Network (Seattle) LLC

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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B7431006

Identifier Type: -

Identifier Source: org_study_id

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