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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

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ClinicalTrials.gov Identifier: NCT00662558
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : November 23, 2009
Last Update Posted : November 23, 2009
Information provided by:

Brief Summary:
To 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

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: celecoxib Drug: tramadol HCL Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 802 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2008
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: celecoxib Drug: celecoxib
200 mg capsules BID for 6 weeks
Active Comparator: tramadol Drug: tramadol HCL
50 mg capsules QID for 6 weeks

Primary Outcome Measures :
  1. Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) [ Time Frame: Week 6 or Early Termination (ET) ]

Secondary Outcome Measures :
  1. Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain [ Time Frame: Baseline, Week 6/ET ]
  2. Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS) [ Time Frame: Baseline, Week 6/ET ]
  3. Patient's Global Assessment of Disease Activity [ Time Frame: Week 6/ET ]
  4. Physician's Global Assessment of Disease Activity [ Time Frame: Week 6/ET ]
  5. Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score [ Time Frame: Baseline, Week 6/ET ]
  6. Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) [ Time Frame: Baseline, Week 6/ET ]
  7. Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: Baseline, Week 6/ET ]
  8. Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores [ Time Frame: Baseline, Week 6/ET ]
  9. Change From Baseline in Work Limitations Questionnaire (WLQ) [ Time Frame: Baseline, Week 6/ET ]
  10. Patient's Global Evaluation of Study Medication [ Time Frame: Weeks 1, 3, and 6/ET ]
  11. Patient's Satisfaction Questionnaire (With Pain Relief Scale) [ Time Frame: Week 6/ET ]
  12. Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) [ Time Frame: Week 6/ET ]
  13. Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ [ Time Frame: Week 6/ET ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662558

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Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00662558     History of Changes
Other Study ID Numbers: A3191338
First Posted: April 21, 2008    Key Record Dates
Results First Posted: November 23, 2009
Last Update Posted: November 23, 2009
Last Verified: October 2009

Keywords provided by Pfizer:
Chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Analgesics, Opioid
Central Nervous System Depressants