Clinical trial NCT02262754: PF-06372865 In Subjects With Chronic Low Back Pain
Official title: A Randomized, Double Blind, Placebo- And Active-controlled, 4 Week, Multi-center, Parallel Group Study Assessing The Analgesic Effect, Safety And Tolerability Of Pf-06372865 In Subjects With Chronic Low Back Pain Using Naproxen As Positive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Low Back Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PF-06372865 In Subjects With Chronic Low Back Pain


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4
timeFrame: Baseline, Week 4
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after the last dose of study treatment (Day 56)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to 28 days after the last dose of study treatment (Day 56)
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Baseline up to Follow-up (44 days)
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Follow-up (44 days)
measure: Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Screening, Baseline, Week 1, 2, 3, 4
measure: Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit
timeFrame: End of treatment (Day 30), follow-up (Day 44)
Secondary outcomes:
measure: Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline
timeFrame: Baseline up to Week 4
measure: Number of Participants Withdrawn Due to Lack of Efficacy
timeFrame: Baseline up to Week 4
measure: Time to Withdrawal Due to Lack of Efficacy
timeFrame: Baseline up to Week 4
measure: Number of Participants Using Rescue Medication
timeFrame: Week 1, 2, 3, 4
measure: Number of Days Participants Used the Rescue Medication
timeFrame: Week 1, 2, 3, 4
measure: Amount of Rescue Medication Used by the Participants
timeFrame: Week 1, 2, 3, 4
measure: Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3
timeFrame: Baseline, Week 1, 2, 3
measure: Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4
timeFrame: Baseline, Week 2, Week 4
measure: Chronic Low Back Pain (CLBP) Responder Index Analysis
timeFrame: Week 1, 2, 3, 4
measure: Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Patient Global Impression of Change (PGI-C) Score
timeFrame: Week 1, 2, 3, 4
measure: Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4
timeFrame: Week 4
measure: Plasma Concentration of PF-06372865
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Plasma Concentration of Naproxen
timeFrame: Baseline, Week 1, 2, 3, 4
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Agave Clinical Research, LLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc.
state: Arizona
city: Anaheim
country: United States
facility: Global Research
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Incorporate
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: S&W Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Hollywood
country: United States
facility: Broward Research Group
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Clinical Research Inc.
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: South Miami
country: United States
facility: Arthritis & Rheumatic Care Center
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Atlanta
country: United States
facility: Better Health Clinical Research, Inc.
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Columbus
country: United States
facility: Family Medicine center
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc./Georgia Pain & Spine Care, Inc.
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc.
state: Georgia
city: Savannah
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Internal medicine
state: Georgia
city: Chicago
country: United States
facility: Chicago Anesthesia Associates
state: Illinois
city: Lake Charles
country: United States
facility: Centex Studies, Inc
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc.
state: Massachusetts
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: Jackson
country: United States
facility: Physician's Surgery Center
state: Mississippi
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Portland
country: United States
facility: Summit Research Network (Oregon), Inc.
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: San Antonio
country: United States
facility: Lee Medical Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: