Chronic Low-back PainPhase 3LBPNCT06595004
A Study to Evaluate the Efficacy and Safety of HCP1004 in Chronic Low-Back Pain Patients
A Phase 3 study testing HCP1004 and RLD2401 in people with Chronic Low-back Pain, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- HCP1004 and RLD2401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Nov 2024to 18 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Chronic Low-back Pain
- Being tested
- HCP1004, RLD2401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1004Drug
Test Drug
RLD2401Drug
Reference drug
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Take HCP1004 twice daily for 12 weeks orally. Receives: Drug: HCP1004 |
| Active Comparator | Active comparator | Take RLD2401 twice daily for 12 weeks orally. Receives: Drug: RLD2401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in VAS
Measured: 4 weeks
Secondary outcomes (5)
Change from baseline in VAS(Visual Analog Scale)
Measured: 8 weeks, 12 weeks
Change from baseline in ODI(Oswestry Disability Index) Score
Measured: 4 weeks, 8 weeks, 12 weeks
Change from baseline in EQ-5D Score
Measured: 4 weeks, 8 weeks, 12 weeks
Change from baseline in GSRS(Gastrointestinal Symptom-Rating Scale) Score
Measured: 4 weeks, 8 weeks, 12 weeks
Usage of rescue medicine
Measured: 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Nov 2024
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595004
- Sponsor's protocol ID
- HM-NEON-301
- Acronym
- LBP
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06595004
- Acronym / sponsor ID
- LBP / HM-NEON-301
- Conditions
- Chronic Low-back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: HCP1004Take HCP1004 twice daily for 12 weeks orally. |
| Active Comparator | Active comparator | Drug: RLD2401Take RLD2401 twice daily for 12 weeks orally. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCP1004Test Drug | Drug | Experimental 1 |
| RLD2401Reference drug | Drug | Active Comparator |
Primary outcome
Change from baseline in VAS
Time frame: 4 weeks
5 secondary outcomes
Change from baseline in VAS(Visual Analog Scale)
Time frame: 8 weeks, 12 weeks
Change from baseline in ODI(Oswestry Disability Index) Score
Time frame: 4 weeks, 8 weeks, 12 weeks
Change from baseline in EQ-5D Score
Time frame: 4 weeks, 8 weeks, 12 weeks
Change from baseline in GSRS(Gastrointestinal Symptom-Rating Scale) Score
Time frame: 4 weeks, 8 weeks, 12 weeks
Usage of rescue medicine
Time frame: 4 weeks, 8 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HCP1004 and RLD2401 in people with Chronic Low-back Pain, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in VAS (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.