Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

Condition(s) targeted: Low Back Pain

Intervention: Diclofenac (Drug); Celecoxib (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment

Secondary outcome:

Subject's quality of life, as measured by the SF-36 Health Survey

Physical examination

Pain relief score

Vital signs

Adverse events

Change from baseline in VAS pain intensity assessment

Categorical pain intensity score

Subject's global assessment score

Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Pfizer Investigational Site, Salvador, BA 40420-000, Brazil

Pfizer Investigational Site, Goiânia, GO 74605-050, Brazil

Pfizer Investigational Site, Goiânia, GO 74075-020, Brazil

Pfizer Investigational Site, Goiânia, GO 74043-110, Brazil

Pfizer Investigational Site, Londrina, PR 86010-010, Brazil

Pfizer Investigational Site, Rio de Janeiro, RJ 21215-020, Brazil

Pfizer Investigational Site, Rio de Janeiro, RJ 21941-590, Brazil

Pfizer Investigational Site, São Paulo, SP 04039-004, Brazil

Pfizer Investigational Site, São Paulo, SP 08270-070, Brazil

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

Link to ClinicalStudyResults.org posting:

Starting date: October 2003
Ending date: October 2004
Last updated: April 2, 2008