Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00640432

Purpose

To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain

Condition	Intervention	Phase
Low Back Pain	Drug: Diclofenac Drug: Celecoxib	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject's quality of life, as measured by the SF-36 Health Survey [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Physical examination [ Time Frame: Days 3 and 7 ] [ Designated as safety issue: Yes ]
Pain relief score [ Time Frame: Days 3 and 7 ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: Days 3 and 7 ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Days 3 and 7 ] [ Designated as safety issue: Yes ]
Change from baseline in VAS pain intensity assessment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Categorical pain intensity score [ Time Frame: Days 3 and 7 ] [ Designated as safety issue: No ]
Subject's global assessment score [ Time Frame: Days 3 and 7 ] [ Designated as safety issue: No ]
Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment:	244
Study Start Date:	October 2003
Study Completion Date:	October 2004

Arms	Assigned Interventions
A: Active Comparator	Drug: Diclofenac 75 mg oral capsule twice daily for 7 days
B: Experimental	Drug: Celecoxib 400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Aged between 18 and 65 years
Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS)
Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode

Exclusion criteria:

Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain
Low back pain from major trauma or visceral disorder
Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640432

Locations

Brazil, BA
Pfizer Investigational Site
Salvador, BA, Brazil, 40420-000
Brazil, GO
Pfizer Investigational Site
Goiânia, GO, Brazil, 74605-050
Pfizer Investigational Site
Goiânia, GO, Brazil, 74075-020
Pfizer Investigational Site
Goiânia, GO, Brazil, 74043-110
Brazil, PR
Pfizer Investigational Site
Londrina, PR, Brazil, 86010-010
Brazil, RJ
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 21215-020
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 21941-590
Brazil, SP
Pfizer Investigational Site
São Paulo, SP, Brazil, 04039-004
Pfizer Investigational Site
São Paulo, SP, Brazil, 08270-070

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191064
Study First Received:	March 17, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00640432 History of Changes
Health Authority:	Brazil: Ministry of Health

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Low Back Pain
Diclofenac
Enzyme Inhibitors
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

ClinicalTrials.gov processed this record on February 04, 2010