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PF-06372865 In Subjects With Chronic Low Back Pain

Last updated on November 15, 2019

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Study Location
Agave Clinical Research, LLC
Mesa, Arizona, 85202 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT02262754
Pfizer
Completed
PF-06372865 In Subjects With Chronic Low Back Pain

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Descriptive Information
Brief Title  ICMJE PF-06372865 In Subjects With Chronic Low Back Pain
Official Title  ICMJE 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
Brief SummaryPF-06372865 In Subjects With Chronic Low Back Pain
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • Drug: PF-06372865
    Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks
  • Drug: Placebo
    Placebo for PF-06372865 and placebo for naproxen daily
  • Drug: Naproxen
    500 mg BID for 4 weeks
Study Arms  ICMJE
  • Experimental: PF-06372865
    Daily BID dosing for 4 weeks
    Intervention: Drug: PF-06372865
  • Placebo Comparator: Placebo
    Daily BID dosing for 4 weeks
    Intervention: Drug: Placebo
  • Active Comparator: Naproxen
    Daily BID dosing for 4 weeks
    Intervention: Drug: Naproxen
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2016)
302
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2014)
300
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion DateAugust 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older 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 NCT02262754
Other Study ID Numbers  ICMJE B7431006
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2016

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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