PF-06372865 In Subjects With Chronic Low Back Pain

NCT02262754

Last updated date
Study Location
Agave Clinical Research, LLC
Mesa, Arizona, 85202, United States
Contact
1-800-718-1021

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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.
Show details

-

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


-

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  3. Torrance, California
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  5. Gainesville, Florida
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  7. West Palm Beach, Florida
  8. Marietta, Georgia
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  11. St. Louis, Missouri
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  13. Winston-Salem, North Carolina
  14. Oklahoma City, Oklahoma
  15. Allentown, Pennsylvania
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  18. Austin, Texas
  19. Dallas, Texas
  20. Houston, Texas
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ALL GENDERS
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Chronic Low Back PainPF-06372865 In Subjects With Chronic Low Back Pain
NCT02262754
  1. Mesa, Arizona
  2. Phoenix, Arizona
  3. Anaheim, California
  4. Fresno, California
  5. North Hollywood, California
  6. Wildomar, California
  7. Stamford, Connecticut
  8. DeLand, Florida
  9. Fort Lauderdale, Florida
  10. Gainesville, Florida
  11. Hollywood, Florida
  12. Jacksonville, Florida
  13. Orlando, Florida
  14. Pembroke Pines, Florida
  15. Port Orange, Florida
  16. South Miami, Florida
  17. South Miami, Florida
  18. Atlanta, Georgia
  19. Blue Ridge, Georgia
  20. Columbus, Georgia
  21. Columbus, Georgia
  22. Marietta, Georgia
  23. Newnan, Georgia
  24. Newnan, Georgia
  25. Savannah, Georgia
  26. Woodstock, Georgia
  27. Woodstock, Georgia
  28. Chicago, Illinois
  29. Lake Charles, Louisiana
  30. Boston, Massachusetts
  31. Methuen, Massachusetts
  32. Jackson, Mississippi
  33. Jackson, Mississippi
  34. Hartsdale, New York
  35. Rochester, New York
  36. Raleigh, North Carolina
  37. Raleigh, North Carolina
  38. Winston-Salem, North Carolina
  39. Portland, Oregon
  40. Duncansville, Pennsylvania
  41. Warwick, Rhode Island
  42. Houston, Texas
  43. San Antonio, Texas
  44. San Antonio, Texas
  45. Norfolk, Virginia
  46. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary PF-06372865 In Subjects With Chronic Low Back Pain
Detailed Description Not 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 Date August 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP