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

NCT00662558 | Completed Phase 3 Results

• 1 other identifier: A3191338
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 60

Brief Summary

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

Conditions

Low Back Pain

Keywords

Chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)

  A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).

  Week 6 or Early Termination (ET)

Secondary Outcomes (13)

• Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain

  Baseline, Week 6/ET

• Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)

  Baseline, Week 6/ET

• Patient's Global Assessment of Disease Activity

  Week 6/ET

• Physician's Global Assessment of Disease Activity

  Week 6/ET

• Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score

  Baseline, Week 6/ET

Study Arms (2)

celecoxib

EXPERIMENTAL

Drug: celecoxib

tramadol

ACTIVE COMPARATOR

Drug: tramadol HCL

Interventions

celecoxib DRUG

200 mg capsules BID for 6 weeks

celecoxib

tramadol HCL DRUG

50 mg capsules QID for 6 weeks

tramadol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)

Sponsors & Collaborators

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

Study Sites (60)

Pfizer Investigational Site

Birmingham, Alabama, 35126, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35235, United States

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Pfizer Investigational Site

Birmingham, Alabama, 35242, United States

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Pfizer Investigational Site

Phoenix, Arizona, 85023, United States

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Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

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Pfizer Investigational Site

Anaheim, California, 92801, United States

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Pfizer Investigational Site

Long Beach, California, 90806, United States

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Pfizer Investigational Site

Oceanside, California, 92056, United States

Location

Pfizer Investigational Site

Sacramento, California, 95823, United States

Location

Pfizer Investigational Site

Sacramento, California, 95825, United States

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Pfizer Investigational Site

Wildomar, California, 92595, United States

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Pfizer Investigational Site

Boulder, Colorado, 80304, United States

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Pfizer Investigational Site

Colorado Springs, Colorado, 80904, United States

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Pfizer Investigational Site

Denver, Colorado, 80220, United States

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Pfizer Investigational Site

Cos Cob, Connecticut, 06807, United States

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Pfizer Investigational Site

Jacksonville, Florida, 32216, United States

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Pfizer Investigational Site

Jacksonville, Florida, 32257, United States

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Pfizer Investigational Site

Pinellas Park, Florida, 33781, United States

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Pfizer Investigational Site

West Palm Beach, Florida, 33409, United States

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Pfizer Investigational Site

Woodstock, Georgia, 30189, United States

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Pfizer Investigational Site

Wichita, Kansas, 67206, United States

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Pfizer Investigational Site

Wichita, Kansas, 67214, United States

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Pfizer Investigational Site

Baton Rouge, Louisiana, 70809, United States

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Pfizer Investigational Site

Baltimore, Maryland, 21218, United States

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Pfizer Investigational Site

Columbia, Maryland, 21045, United States

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Pfizer Investigational Site

Rockville, Maryland, 20852, United States

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Pfizer Investigational Site

Wheaton, Maryland, 20902, United States

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Pfizer Investigational Site

Saint Paul, Minnesota, 55108, United States

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Pfizer Investigational Site

Jackson, Mississippi, 39202, United States

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Pfizer Investigational Site

Springfield, Missouri, 65807, United States

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Pfizer Investigational Site

St Louis, Missouri, 63141, United States

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Pfizer Investigational Site

Omaha, Nebraska, 68134, United States

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Pfizer Investigational Site

New Windsor, New York, 12553, United States

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Pfizer Investigational Site

New York, New York, 10022-1009, United States

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Pfizer Investigational Site

Rochester, New York, 14618, United States

Location

Pfizer Investigational Site

Williamsville, New York, 14221, United States

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Pfizer Investigational Site

Portland, Oregon, 97219, United States

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Pfizer Investigational Site

Bridgeville, Pennsylvania, 15017, United States

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Pfizer Investigational Site

Camp Hill, Pennsylvania, 17011, United States

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Pfizer Investigational Site

Columbia, South Carolina, 29204, United States

Location

Pfizer Investigational Site

North Charleston, South Carolina, 29406, United States

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Pfizer Investigational Site

Bristol, Tennessee, 37620, United States

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Pfizer Investigational Site

Collierville, Tennessee, 38017, United States

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Pfizer Investigational Site

Johnson City, Tennessee, 37601, United States

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Pfizer Investigational Site

Kingsport, Tennessee, 37660, United States

Location

Pfizer Investigational Site

New Tazewell, Tennessee, 37825, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Beaumont, Texas, 77701, United States

Location

Pfizer Investigational Site

Beaumont, Texas, 77706, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75240, United States

Location

Pfizer Investigational Site

Grapevine, Texas, 76051, United States

Location

Pfizer Investigational Site

Houston, Texas, 77074, United States

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Pfizer Investigational Site

Lake Jackson, Texas, 77566, United States

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Pfizer Investigational Site

San Angelo, Texas, 76904, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78217, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84107, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23294, United States

Location

Pfizer Investigational Site

Weber City, Virginia, 24290, United States

Location

Related Links

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

MeSH Terms

Conditions

Low Back Pain

Interventions

Celecoxib; Tramadol

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: April 21, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 21, 2021
• Results First Posted: November 23, 2009

Record last verified: 2021-01

Locations

US (60)