Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Drug: Tramadol Hydrochloride 50mg; Drug: Celebrex 200mg

• Study Type: Interventional
• Enrollment: 754
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Rio Piedras, Puerto Rico
    • Pfizer Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States
      • Pfizer Investigational Site
    • Scottsdale, Arizona, United States
      • Pfizer Investigational Site
    • Tucson, Arizona, United States
      • Pfizer Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States
      • Pfizer Investigational Site
  • California
    • Anaheim, California, United States
      • Pfizer Investigational Site
    • La Mesa, California, United States
      • Pfizer Investigational Site
    • Long Beach, California, United States
      • Pfizer Investigational Site
    • Oceanside, California, United States
      • Pfizer Investigational Site
    • Paramount, California, United States
      • Pfizer Investigational Site
    • Sacramento, California, United States
      • Pfizer Investigational Site
    • San Francisco, California, United States
      • Pfizer Investigational Site
    • San Luis Obispo, California, United States
      • Pfizer Investigational Site
    • Tustin, California, United States
      • Pfizer Investigational Site
    • Vista, California, United States
      • Pfizer Investigational Site
  • Colorado
    • Boulder, Colorado, United States
      • Pfizer Investigational Site
    • Colorado Springs, Colorado, United States
      • Pfizer Investigational Site
    • Denver, Colorado, United States
      • Pfizer Investigational Site
  • Connecticut
    • Cos Cob, Connecticut, United States
      • Pfizer Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States
      • Pfizer Investigational Site
  • Florida
    • Miami, Florida, United States
      • Pfizer Investigational Site
    • Pembroke Pines, Florida, United States
      • Pfizer Investigational Site
    • West Palm Beach, Florida, United States
      • Pfizer Investigational Site
  • Georgia
    • Decatur, Georgia, United States
      • Pfizer Investigational Site
    • Woodstock, Georgia, United States
      • Pfizer Investigational Site
  • Illinois
    • Libertyville, Illinois, United States
      • Pfizer Investigational Site
    • Morton Grove, Illinois, United States
      • Pfizer Investigational Site
  • Kansas
    • Arkansas City, Kansas, United States
      • Pfizer Investigational Site
    • Overland Park, Kansas, United States
      • Pfizer Investigational Site
    • Wichita, Kansas, United States
      • Pfizer Investigational Site
  • Kentucky
    • Madisonville, Kentucky, United States
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States
      • Pfizer Investigational Site
    • Wheaton, Maryland, United States
      • Pfizer Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States
      • Pfizer Investigational Site
  • Missouri
    • Kansas City, Missouri, United States
      • Pfizer Investigational Site
    • Saint Louis, Missouri, United States
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States
      • Pfizer Investigational Site
  • New York
    • Brooklyn, New York, United States
      • Pfizer Investigational Site
    • New York, New York, United States
      • Pfizer Investigational Site
    • Rochester, New York, United States
      • Pfizer Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States
      • Pfizer Investigational Site
  • Oregon
    • Medford, Oregon, United States
      • Pfizer Investigational Site
    • Portland, Oregon, United States
      • Pfizer Investigational Site
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States
      • Pfizer Investigational Site
    • Duncansville, Pennsylvania, United States
      • Pfizer Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States
      • Pfizer Investigational Site
    • Columbia, South Carolina, United States
      • Pfizer Investigational Site
  • Tennessee
    • Johnson City, Tennessee, United States
      • Pfizer Investigational Site
    • New Tazewell, Tennessee, United States
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States
      • Pfizer Investigational Site
    • San Angelo, Texas, United States
      • Pfizer Investigational Site
    • San Antonio, Texas, United States
      • Pfizer Investigational Site
  • Virginia
    • Arlington, Virginia, United States
      • Pfizer Investigational Site
    • Danville, Virginia, United States
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: February 9, 2006
• First Submitted That Met QC Criteria: February 9, 2006
• First Posted (Estimate): February 13, 2006

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Cyclooxygenase 2 Inhibitors; Celecoxib; Tramadol
• Other Study ID Numbers: A3191165