New NSAID aims to match existing drug for back pain relief
NCT ID NCT06595004
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 3 study tested a new drug called HCP1004 against an existing painkiller (RLD2401) in 310 adults with chronic low-back pain lasting at least 3 months. The goal was to see if HCP1004 works just as well for pain and function, while monitoring safety. Participants took the drugs daily for at least 12 weeks, and researchers measured pain levels using a standard scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HCP1004 (a nonsteroidal anti-inflammatory drug, NSAID)
- What this could lead to
- If successful, this could offer a new NSAID option for managing chronic low-back pain with similar effectiveness to existing drugs.
- What could go wrong
- This is a non-inferiority trial, meaning it aims to show HCP1004 is not worse than the reference drug, not that it is better. Results may not show a meaningful advantage, and NSAIDs carry risks like stomach ulcers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
310 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hanyang University Seoul Hospital
Seoul, Seoul, 04763, South Korea
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