Clinical trial NCT00649610: Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain
Official title: Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: acute low back pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 340
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: The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.


Eligibility criteria: Inclusion Criteria:

* Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
* Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
* History of at least 1 reported episode of acute low back pain in the last 5 years

Exclusion Criteria:

* History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
* Moderate to severe scoliosis
* Back pain due to major trauma or visceral disorder
* Unwilling to refrain from commencing concomitant physiotherapy
* Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
* Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation
* Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception

Primary outcomes:
measure: Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline
timeFrame: Day 3
Secondary outcomes:
measure: Patient global evaluation
timeFrame: Day 3 and Day 7
measure: Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire
timeFrame: Day 7
measure: Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)
timeFrame: Day 7
measure: Pain Relief
timeFrame: Day 3 and Day 7
measure: Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia
timeFrame: Day 7
measure: VAS Pain Intensity (0-100 mm)
timeFrame: Day 7
measure: Categorical Pain Intensity
timeFrame: Day 3 and Day 7
Other outcomes:
Locations:
city: Bs. As.
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Goiania
country: Brazil
facility: Pfizer Investigational Site
state: Goias
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: Parana
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Petropolis
country: Brazil
facility: Pfizer Investigational Site
state: Rio de Janeiro
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: D.c.
city: Bogota D.c
country: Colombia
facility: Pfizer Investigational Site
city: Cali-valle
country: Colombia
facility: Pfizer Investigational Site
city: Cartago City
country: Costa Rica
facility: Pfizer Investigational Site
state: Cartago
city: Hatillo
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Quito
country: Ecuador
facility: Pfizer Investigational Site
state: Pichincha
city: Toluca
country: Mexico
facility: Pfizer Investigational Site
state: Edo. de Mexico
city: Zapopan
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Puebla
country: Mexico
facility: Pfizer Investigational Site
city: Puebla
country: Mexico
facility: Pfizer Investigational Site
city: Puebla
country: Mexico
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: DF
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: DF
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: DF
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: