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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Drug: HCP1004; Drug: RLD2401

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 04763
      • Hanyang University Seoul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 1; Take HCP1004 twice daily for 12 weeks orally.	Drug: HCP1004; Test Drug
Active Comparator: Active Comparator; Take RLD2401 twice daily for 12 weeks orally.	Drug: RLD2401; Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in VAS	4 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2024
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): June 18, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HM-NEON-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No