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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: valdecoxib
  • valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
• Drug: diclofenac
  • diclofenac 75 mg twice daily (BID) for 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline
  • Time Frame: Day 3
    Safety Issue?: No

Secondary Measures

• Patient global evaluation
  • Time Frame: Day 3 and Day 7
    Safety Issue?: No
• Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire
  • Time Frame: Day 7
    Safety Issue?: No
• Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)
  • Time Frame: Day 7
    Safety Issue?: No
• Pain Relief
  • Time Frame: Day 3 and Day 7
    Safety Issue?: No
• 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
  • Time Frame: Day 7
    Safety Issue?: Yes
• VAS Pain Intensity (0-100 mm)
  • Time Frame: Day 7
    Safety Issue?: No
• Categorical Pain Intensity
  • Time Frame: Day 3 and Day 7
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00649610

Study ID Number: A3471012

ClinicalTrials.gov Identifier: NCT00649610

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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