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

NCT06595004 | Completed Phase 3

• 1 other identifier: HM-NEON-301
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in VAS

  4 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Experimental 1

EXPERIMENTAL

Take HCP1004 twice daily for 12 weeks orally.

Drug: HCP1004

Active Comparator

ACTIVE COMPARATOR

Take RLD2401 twice daily for 12 weeks orally.

Drug: RLD2401

Interventions

HCP1004 DRUG

Test Drug

Experimental 1

RLD2401 DRUG

Reference drug

Active Comparator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \~ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanyang University Seoul Hospital

Seoul, Seoul, 04763, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: November 22, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)