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

NCT ID: NCT06595004

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-22
• Study Completion Date: 2025-06-18

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

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental 1

Take HCP1004 twice daily for 12 weeks orally.

Group Type: EXPERIMENTAL

HCP1004

Intervention Type: DRUG

Test Drug

Active Comparator

Take RLD2401 twice daily for 12 weeks orally.

Group Type: ACTIVE_COMPARATOR

RLD2401

Intervention Type: DRUG

Reference drug

Interventions

HCP1004

Test Drug

Intervention Type: DRUG

RLD2401

Reference drug

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hanyang University Seoul Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

HM-NEON-301

Identifier Type: -

Identifier Source: org_study_id