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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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00662558
First received: December 6, 2007
Last updated: October 21, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Low Back Pain
Drug: celecoxib
Drug: tramadol HCL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) [ Time Frame: Week 6 or Early Termination (ET) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS) [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Patient's Global Assessment of Disease Activity [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of Disease Activity [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Change From Baseline in Work Limitations Questionnaire (WLQ) [ Time Frame: Baseline, Week 6/ET ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: Weeks 1, 3, and 6/ET ] [ Designated as safety issue: No ]
  • Patient's Satisfaction Questionnaire (With Pain Relief Scale) [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]
  • Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]
  • Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ [ Time Frame: Week 6/ET ] [ Designated as safety issue: No ]

Enrollment: 802
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: celecoxib Drug: celecoxib
200 mg capsules BID for 6 weeks
Active Comparator: tramadol Drug: tramadol HCL
50 mg capsules QID for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662558

  Show 60 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00662558     History of Changes
Other Study ID Numbers: A3191338
Study First Received: December 6, 2007
Results First Received: September 10, 2009
Last Updated: October 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Chronic low back pain

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

ClinicalTrials.gov processed this record on November 25, 2014