Clinical trial NCT00640432: Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment
timeFrame: Day 3
Secondary outcomes:
measure: Subject's quality of life, as measured by the SF-36 Health Survey
timeFrame: Day 7
measure: Physical examination
timeFrame: Days 3 and 7
measure: Pain relief score
timeFrame: Days 3 and 7
measure: Vital signs
timeFrame: Days 3 and 7
measure: Adverse events
timeFrame: Days 3 and 7
measure: Change from baseline in VAS pain intensity assessment
timeFrame: Day 7
measure: Categorical pain intensity score
timeFrame: Days 3 and 7
measure: Subject's global assessment score
timeFrame: Days 3 and 7
measure: Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability
timeFrame: Day 7
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: BA
city: Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Londrina
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: