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
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
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.
Male or female ≥ 19 years of age with following criteria:
Exclusion Criteria:
Take HCP1004 twice daily for 12 weeks orally.
Drug: HCP1004
Take RLD2401 twice daily for 12 weeks orally.
Drug: RLD2401
Test Drug
Reference drug
Change from baseline in VAS
Time frame: 4 weeks
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
Plan to share: No
No publications or documents are linked to this record.
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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Hanmi Pharmaceutical Company Limited