Clinical trial NCT00662558: 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: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Chronic low back pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 802
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)
timeFrame: Week 6 or Early Termination (ET)
Secondary outcomes:
measure: Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain
timeFrame: Baseline, Week 6/ET
measure: Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)
timeFrame: Baseline, Week 6/ET
measure: Patient's Global Assessment of Disease Activity
timeFrame: Week 6/ET
measure: Physician's Global Assessment of Disease Activity
timeFrame: Week 6/ET
measure: Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score
timeFrame: Baseline, Week 6/ET
measure: Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
timeFrame: Baseline, Week 6/ET
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
timeFrame: Baseline, Week 6/ET
measure: Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores
timeFrame: Baseline, Week 6/ET
measure: Change From Baseline in Work Limitations Questionnaire (WLQ)
timeFrame: Baseline, Week 6/ET
measure: Patient's Global Evaluation of Study Medication
timeFrame: Weeks 1, 3, and 6/ET
measure: Patient's Satisfaction Questionnaire (With Pain Relief Scale)
timeFrame: Week 6/ET
measure: Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
timeFrame: Week 6/ET
measure: Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ
timeFrame: Week 6/ET
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Wildomar
country: United States
facility: Pfizer Investigational Site
state: California
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Cos Cob
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Woodstock
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Saint Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: New Windsor
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Williamsville
country: United States
facility: Pfizer Investigational Site
state: New York
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bridgeville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Camp Hill
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: North Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Collierville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: New Tazewell
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Grapevine
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Angelo
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Weber City
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: