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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: March 17, 2008
Last updated: April 2, 2008
Last verified: March 2008
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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:

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 ]

Secondary Outcome Measures:
  • Subject's quality of life, as measured by the SF-36 Health Survey [ Time Frame: Day 7 ]
  • Physical examination [ Time Frame: Days 3 and 7 ]
  • Pain relief score [ Time Frame: Days 3 and 7 ]
  • Vital signs [ Time Frame: Days 3 and 7 ]
  • Adverse events [ Time Frame: Days 3 and 7 ]
  • Change from baseline in VAS pain intensity assessment [ Time Frame: Day 7 ]
  • Categorical pain intensity score [ Time Frame: Days 3 and 7 ]
  • Subject's global assessment score [ Time Frame: Days 3 and 7 ]
  • Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability [ Time Frame: Day 7 ]

Enrollment: 244
Study Start Date: October 2003
Study Completion Date: October 2004
Arms Assigned Interventions
Active Comparator: A Drug: Diclofenac
75 mg oral capsule twice daily for 7 days
Experimental: B 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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00640432

Pfizer Investigational Site
Salvador, BA, Brazil, 40420-000
Pfizer Investigational Site
Goiânia, GO, Brazil, 74043-110
Pfizer Investigational Site
Goiânia, GO, Brazil, 74075-020
Pfizer Investigational Site
Goiânia, GO, Brazil, 74605-050
Pfizer Investigational Site
Londrina, PR, Brazil, 86010-010
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 21215-020
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 21941-590
Pfizer Investigational Site
São Paulo, SP, Brazil, 04039-004
Pfizer Investigational Site
São Paulo, SP, Brazil, 08270-070
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00640432     History of Changes
Other Study ID Numbers: A3191064
Study First Received: March 17, 2008
Last Updated: April 2, 2008

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on August 17, 2017