None listed
Conditions
Interventions
Etoricoxib 60 mg Type of group
Etoricoxib 60 mg is administered orally for 4 weeks in patients with chronic low back pain.
Group name:Diclofenac 150 mg Type of group
Diclofenac 150 mg is given for 4 weeks in patients with chronic low back pain.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: The patient is a man or a woman> 18 years of age. The patient presents a low back pain that complies with Class 1 or 2 according to the Vertebral Column Disorders of the Quebec Task Force. The patient has felt back pain during the last 3 months, as minimum, and most days of last month.
Exclusion criteria
Exclusion criteria: The patient has undergone surgery for low back pain in the last 6 months. The patient suffers from lumbalgia due to secondary causes, such as malignant disease, inflammatory disease. The patient has experienced clinical depression in the last 1 year or is under active treatment for depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The end point of primary efficacy is the Low Back Pain Intensity Scale (VAS from 0 to 100 mm) Measure:Efficacy analysis is the modified treatment intention approach Timepoints:4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Statistical and clinical review of the incidence of adverse events and laboratory values and vital signs. Measure:The safety of etoricoxib 60 mg administered daily and diclofenac sodium 150 mg. Timepoints:4 weeks | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed