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

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Diclofenac; Drug: Celecoxib

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment	Day 3

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion (ACTUAL): October 1, 2004

Study Registration Dates

• First Submitted: March 17, 2008
• First Submitted That Met QC Criteria: March 20, 2008
• First Posted (ESTIMATE): March 21, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib; Diclofenac
• Other Study ID Numbers: A3191064