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

Hanmi Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Chronic Low-back Pain

Treatments: Drug: RLD2401; Drug: HCP1004

Study type: Interventional

Funder types: Industry

Identifiers

NCT06595004

HM-NEON-301

Details and patient eligibility

About

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

Enrollment: 286 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 2 patient groups

Experimental 1

Experimental group

Description:

Take HCP1004 twice daily for 12 weeks orally.

Treatment:

Drug: HCP1004

Active Comparator

Active Comparator group

Description:

Take RLD2401 twice daily for 12 weeks orally.

Treatment:

Drug: RLD2401