Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of HCP1004 in Chronic Low-Back Pain Patients
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2025
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06595004
Start Date
November 22 2024
End Date
June 18 2025
Last Update
December 15 2025
Active Locations (1)
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1
Hanyang University Seoul Hospital
Seoul, Seoul, South Korea, 04763