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New NSAID aims to match existing drug for back pain relief

NCT ID NCT06595004

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

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

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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