Evaluating HCP1004 for chronic low-back pain
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
This study is testing a new treatment called HCP1004 to see if it can help people with chronic low-back pain feel better and is as safe as another existing treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hanmi Pharmaceutical Company Limited Industry-sponsored |
| Locations | 1 site (Seongdong-Gu, Seoul) |
| Trial ID | NCT06595004 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial is designed to assess the efficacy and safety of HCP1004 in patients suffering from chronic low-back pain. It is a randomized, double-blind, active-controlled study that compares HCP1004 to RLD2401, focusing on patients with chronic low-back pain lasting at least three months. The study aims to determine whether HCP1004 is non-inferior to the comparator in terms of pain relief and safety. Participants will be monitored for their pain levels and any adverse effects throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with chronic low-back pain lasting at least three months and a need for daily NSAID therapy.
Not a fit: Patients with serious underlying conditions causing low-back pain or recent trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from chronic low-back pain.
How similar studies have performed: Other studies have shown promise in treating chronic low-back pain with similar approaches, but the specific efficacy of HCP1004 remains to be established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seongdong-Gu, Seoul
- Hanyang University Seoul Hospital — Seongdong-Gu, Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jee Won Shon
- Email: jeewon.shon@hanmi.co.kr
- Phone: 82-2-410-9037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.