search
Back to results

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

Primary Purpose

Back Pain

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tramadol Hydrochloride 50mg
Celebrex 200mg
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
February 9, 2006
Last Updated
March 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00290901
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
754 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tramadol Hydrochloride 50mg
Intervention Type
Drug
Intervention Name(s)
Celebrex 200mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Paramount
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
San Luis Obispo
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Tustin
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Vista
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Boulder
State/Province
Colorado
Country
United States
Facility Name
Pfizer Investigational Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Pfizer Investigational Site
City
Cos Cob
State/Province
Connecticut
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Pfizer Investigational Site
City
Woodstock
State/Province
Georgia
Country
United States
Facility Name
Pfizer Investigational Site
City
Libertyville
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Morton Grove
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Arkansas City
State/Province
Kansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Madisonville
State/Province
Kentucky
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Pfizer Investigational Site
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Pfizer Investigational Site
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Pfizer Investigational Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Pfizer Investigational Site
City
Camp Hill
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Johnson City
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
New Tazewell
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
San Angelo
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Arlington
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Danville
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Rio Piedras
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191165&StudyName=Celebrex+vs+Tramadol+in+the+treatment+of+chronic+lower+back+pain%2E+
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs