Chronic Low-back Pain
Conditions
Brief summary
A Randomized, Double-blind, Active-controlled, Non-inferiority, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HCP1004 as compared to RLD2401 in Chronic Low-Back Pain Patients
Interventions
DRUGHCP1004
Test Drug
DRUGRLD2401
Reference drug
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Chronic low back pain ≥3 months in duration 2. Quebec Task Force in Spinal Disorders class 1 or 2 3. 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 4. 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
1. Diagnosed with certain serious diseases that may be secondary causes of Low back pain (e.g., tumors, infectious diseases, gout, etc.) 2. Clinically significant neurological disease or low back pain due to trauma (e.g. spinal fracture) within the past 6 months 3. 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 4. 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. 5. Active gastritis, inflammatory bowel syndrome, peptic ulcer or any history of gastrointestinal bleeding duodenal ulceration within the past 3 months 6. Patients with history of platelet-related disease or bleeding disorder within the past 6 months or who are taking anti-coagulants 7. Patients with ischemic heart disease or severe cerebrovascular disease within the past 6 months 8. Bronchial asthma or Uncontrolled Diabete Mellitus or Hypertension 9. Use of peptic ulcer treatment (H2-blockers, PPI, PCAB series or Misoprostol), psychotropic drugs, narcotic analgesics or systemic corticosteroids within past 4 weeks 10. Severe renal dysfunction (Creatinine clearance ≥ 30mL/min ) or Severe liver dysfunction (AST or AST ≥ 3 x UNL) 11. History of malignant tumors within past 5 years 12. Positive to pregnancy test, nursing mother, intention on pregnancy 13. Considered by investigator as not appropriate to participate in the study with other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in VAS | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in VAS(Visual Analog Scale) | 8 weeks, 12 weeks |
| Change from baseline in ODI(Oswestry Disability Index) Score | 4 weeks, 8 weeks, 12 weeks |
| Change from baseline in EQ-5D Score | 4 weeks, 8 weeks, 12 weeks |
| Change from baseline in GSRS(Gastrointestinal Symptom-Rating Scale) Score | 4 weeks, 8 weeks, 12 weeks |
| Usage of rescue medicine | 4 weeks, 8 weeks, 12 weeks |
Countries
South Korea
Outcome results
None listed