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

• 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

• Active Comparator: Arm 1
  
  Intervention: Drug: valdecoxib
• Active Comparator: Arm 2
  
  Intervention: Drug: diclofenac

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