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A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35126 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- The subject presents with duration of chronic low back pain of > 3 months requiring
regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have
been the sole analgesic used

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

- The subject has chronic low back pain, which is neurologic in etiology (i.e.,
radiculopathy, neuropathy, myelopathy)

NCT00662558
Pfizer
Completed
A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain

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Descriptive Information
Brief Title  ICMJE A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain
Official Title  ICMJE A Six Week Double-Blind, Randomized, Multicenter Comparison Study Of The Analgesic Effectiveness Of Celecoxib 200 Mg BID Compared To Tramadol Hydrochloride 50 Mg QID In Subjects With Chronic Low Back Pain
Brief SummaryTo compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: celecoxib
    200 mg capsules BID for 6 weeks
  • Drug: tramadol HCL
    50 mg capsules QID for 6 weeks
Study Arms  ICMJE
  • Experimental: celecoxib
    Intervention: Drug: celecoxib
  • Active Comparator: tramadol
    Intervention: Drug: tramadol HCL
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 18, 2008)
802
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2008)
776
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion DateSeptember 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used

Exclusion Criteria:

  • The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 NCT00662558
Other Study ID Numbers  ICMJE A3191338
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2009

ICMJE     Data element required by the

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

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