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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00290901
Collaborator
(none)
754
Enrollment
54
Locations
14
Patients Per Site

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tramadol Hydrochloride 50mg
  • Drug: Celebrex 200mg
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Phoenix Arizona United States
2 Pfizer Investigational Site Scottsdale Arizona United States
3 Pfizer Investigational Site Tucson Arizona United States
4 Pfizer Investigational Site Little Rock Arkansas United States
5 Pfizer Investigational Site Anaheim California United States
6 Pfizer Investigational Site La Mesa California United States
7 Pfizer Investigational Site Long Beach California United States
8 Pfizer Investigational Site Oceanside California United States
9 Pfizer Investigational Site Paramount California United States
10 Pfizer Investigational Site Sacramento California United States
11 Pfizer Investigational Site San Francisco California United States
12 Pfizer Investigational Site San Luis Obispo California United States
13 Pfizer Investigational Site Tustin California United States
14 Pfizer Investigational Site Vista California United States
15 Pfizer Investigational Site Boulder Colorado United States
16 Pfizer Investigational Site Colorado Springs Colorado United States
17 Pfizer Investigational Site Denver Colorado United States
18 Pfizer Investigational Site Cos Cob Connecticut United States
19 Pfizer Investigational Site Washington District of Columbia United States
20 Pfizer Investigational Site Miami Florida United States
21 Pfizer Investigational Site Pembroke Pines Florida United States
22 Pfizer Investigational Site West Palm Beach Florida United States
23 Pfizer Investigational Site Decatur Georgia United States
24 Pfizer Investigational Site Woodstock Georgia United States
25 Pfizer Investigational Site Libertyville Illinois United States
26 Pfizer Investigational Site Morton Grove Illinois United States
27 Pfizer Investigational Site Arkansas City Kansas United States
28 Pfizer Investigational Site Overland Park Kansas United States
29 Pfizer Investigational Site Wichita Kansas United States
30 Pfizer Investigational Site Madisonville Kentucky United States
31 Pfizer Investigational Site Baltimore Maryland United States
32 Pfizer Investigational Site Wheaton Maryland United States
33 Pfizer Investigational Site Jackson Mississippi United States
34 Pfizer Investigational Site Kansas City Missouri United States
35 Pfizer Investigational Site Saint Louis Missouri United States
36 Pfizer Investigational Site Omaha Nebraska United States
37 Pfizer Investigational Site Brooklyn New York United States
38 Pfizer Investigational Site New York New York United States
39 Pfizer Investigational Site Rochester New York United States
40 Pfizer Investigational Site Raleigh North Carolina United States
41 Pfizer Investigational Site Medford Oregon United States
42 Pfizer Investigational Site Portland Oregon United States
43 Pfizer Investigational Site Camp Hill Pennsylvania United States
44 Pfizer Investigational Site Duncansville Pennsylvania United States
45 Pfizer Investigational Site Charleston South Carolina United States
46 Pfizer Investigational Site Columbia South Carolina United States
47 Pfizer Investigational Site Johnson City Tennessee United States
48 Pfizer Investigational Site New Tazewell Tennessee United States
49 Pfizer Investigational Site Austin Texas United States
50 Pfizer Investigational Site San Angelo Texas United States
51 Pfizer Investigational Site San Antonio Texas United States
52 Pfizer Investigational Site Arlington Virginia United States
53 Pfizer Investigational Site Danville Virginia United States
54 Pfizer Investigational Site Rio Piedras Puerto Rico

Sponsors and Collaborators

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

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00290901
Other Study ID Numbers:
  • A3191165
First Posted:
Feb 13, 2006
Last Update Posted:
Mar 3, 2021
Last Verified:
Mar 1, 2021
Additional relevant MeSH terms:
Back Pain
Celecoxib
Tramadol

Study Results

No Results Posted as of Mar 3, 2021