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
1 other identifier
interventional
244
1 country
9
Brief Summary
To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 low-back-pain
Started Oct 2003
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 17, 2008
CompletedFirst Posted
Study publicly available on registry
March 21, 2008
CompletedFebruary 2, 2021
January 1, 2021
March 17, 2008
January 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment
Day 3
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
A
ACTIVE COMPARATORB
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Pfizer Investigational Site
Salvador, Estado de Bahia, 40420-000, Brazil
Pfizer Investigational Site
Goiânia, Goiás, 74043-110, Brazil
Pfizer Investigational Site
Goiânia, Goiás, 74075-020, Brazil
Pfizer Investigational Site
Goiânia, Goiás, 74605-050, Brazil
Pfizer Investigational Site
Londrina, Paraná, 86010-010, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 21215-020, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, 04039-004, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, 08270-070, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2008
First Posted
March 21, 2008
Study Start
October 1, 2003
Study Completion
October 1, 2004
Last Updated
February 2, 2021
Record last verified: 2021-01