A Study to Evaluate the Efficacy and Safety of HCP1004 in Chronic Low-Back Pain Patients

Inclusion criteria

• Chronic low back pain ≥3 months in duration
• Quebec Task Force in Spinal Disorders class 1 or 2
• Male or female ≥ 19 years of age with following criteria:

• ≥ 50 years
• 19~ 49 years with history of gastric or duodenal ulcers within the past 5 years
• Low back pain disease condition expected to require daily NSAIDs therapy for at least 12 weeks
• VAS ≥ 40 (at Visit 2) (If there are any treatment history to affect the efficacy evaluation of low back pain, VAS after washout period have to meet the criteria; 20% over baseline VAS or change from baseline VAS ≥10)

Exclusion criteria

• Diagnosed with certain serious diseases that may be secondary causes of Low back pain (e.g., tumors, infectious diseases, gout, etc.)
• Clinically significant neurological disease or low back pain due to trauma (e.g. spinal fracture) within the past 6 months
• Invasive procedures (using corticosteroids) in the lumbar region within the past 3 months or surgical intervention within the past 6 months or need to such interventions during the study
• History of non-drug treatment of the lumbar region (e.g., physical therapy) for the purpose of alleviating low back pain within 7 days prior to the screening visit.
• Active gastritis, inflammatory bowel syndrome, peptic ulcer or any history of gastrointestinal bleeding duodenal ulceration within the past 3 months
• Patients with history of platelet-related disease or bleeding disorder within the past 6 months or who are taking anti-coagulants
• Patients with ischemic heart disease or severe cerebrovascular disease within the past 6 months
• Bronchial asthma or Uncontrolled Diabete Mellitus or Hypertension
• Use of peptic ulcer treatment (H2-blockers, PPI, PCAB series or Misoprostol), psychotropic drugs, narcotic analgesics or systemic corticosteroids within past 4 weeks
• Severe renal dysfunction (Creatinine clearance ≥ 30mL/min ) or Severe liver dysfunction (AST or AST ≥ 3 x UNL)
• History of malignant tumors within past 5 years
• Positive to pregnancy test, nursing mother, intention on pregnancy
• Considered by investigator as not appropriate to participate in the study with other reason