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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00640432
First received: March 17, 2008
Last updated: April 2, 2008
Last verified: March 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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
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

  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
Pfizer Investigational Site
Salvador, BA, Brazil, 40420-000
Pfizer Investigational Site
Goiânia, GO, Brazil, 74605-050
Pfizer Investigational Site
Goiânia, GO, Brazil, 74075-020
Pfizer Investigational Site
Goiânia, GO, Brazil, 74043-110
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Diclofenac
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014