CClinicalTrials.gg
CompletedNCT06595004LBPUpdated Dec 15, 2025

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

A Phase 3 interventional study of HCP1004 and RLD2401 in Chronic Low-back Pain, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
310
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Low-back Pain
03

In context

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
310 participants (actual)

Study arms

  • Experimental
    Experimental 1

    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

  • DrugHCP1004

    Test Drug

  • DrugRLD2401

    Reference drug

06

What researchers measure

Primary outcomes

  1. Change from baseline in VAS

    Time frame: 4 weeks

Secondary outcomes

  1. Change from baseline in VAS(Visual Analog Scale)

    Time frame: 8 weeks, 12 weeks

  2. Change from baseline in ODI(Oswestry Disability Index) Score

    Time frame: 4 weeks, 8 weeks, 12 weeks

  3. Change from baseline in EQ-5D Score

    Time frame: 4 weeks, 8 weeks, 12 weeks

  4. Change from baseline in GSRS(Gastrointestinal Symptom-Rating Scale) Score

    Time frame: 4 weeks, 8 weeks, 12 weeks

  5. Usage of rescue medicine

    Time frame: 4 weeks, 8 weeks, 12 weeks

07

Study locations

1 site
  • Hanyang University Seoul Hospital
    Seoul, Seoul 04763, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06595004
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Nov 22, 2024
Primary completion
Jun 18, 2025
Completion
Jun 18, 2025
Last update
Dec 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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