Clinical trial NCT00290901: Celebrex vs Tramadol in the Treatment of Chronic Lower 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: PHASE4
Conditions: Back Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.


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: 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.
Secondary outcomes:
measure: To compare the effects of treatment with celecoxib 200 mg BID and tramadol hydrochloride 50 mg QID on improvement in functionality and quality of life in subjects with chronic low back pain.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
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: La Mesa
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: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Luis Obispo
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Vista
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: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Woodstock
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Libertyville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Morton Grove
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Arkansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Brooklyn
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: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Camp Hill
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Johnson City
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: San Angelo
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Danville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Rio Piedras
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: