Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00290901

Purpose

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	Intervention	Phase
Back Pain	Drug: Tramadol Hydrochloride 50mg Drug: Celebrex 200mg	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Tramadol Tramadol hydrochloride Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

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.

Estimated Enrollment:	754
Study Start Date:	March 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290901

Show 55 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A3191165
Study First Received:	February 9, 2006
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00290901 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Tramadol
Cyclooxygenase Inhibitors
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Narcotics
Pain
Back Pain

Pharmacologic Actions
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 05, 2009