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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

NCT ID: NCT00662558

Last Updated: 2021-02-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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celecoxib

Group Type EXPERIMENTAL

celecoxib

Intervention Type DRUG

200 mg capsules BID for 6 weeks

tramadol

Group Type ACTIVE_COMPARATOR

tramadol HCL

Intervention Type DRUG

50 mg capsules QID for 6 weeks

Interventions

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celecoxib

200 mg capsules BID for 6 weeks

Intervention Type DRUG

tramadol HCL

50 mg capsules QID for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Long Beach, California, United States

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Oceanside, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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Wildomar, California, United States

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Boulder, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Cos Cob, Connecticut, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Pinellas Park, Florida, United States

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West Palm Beach, Florida, United States

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Woodstock, Georgia, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Rockville, Maryland, United States

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Wheaton, Maryland, United States

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Saint Paul, Minnesota, United States

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Jackson, Mississippi, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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New Windsor, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Williamsville, New York, United States

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Portland, Oregon, United States

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Bridgeville, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Columbia, South Carolina, United States

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North Charleston, South Carolina, United States

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Bristol, Tennessee, United States

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Collierville, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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New Tazewell, Tennessee, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Grapevine, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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San Angelo, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Pfizer Investigational Site

Weber City, Virginia, United States

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Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191338&StudyName=A%20Six%20Week%20Study%20Of%20The%20Pain%20Relieving%20Effects%20Of%20Celecoxib%20200%20Mg%20Twice%20Daily%20Compared%20To%20Tramadol%2050%20Mg%20Four%20Times%20Daily%20In%20

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

Other Identifiers

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A3191338

Identifier Type: -

Identifier Source: org_study_id

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