A Study to Evaluate the Efficacy and Safety of HCP1004 in Chronic Low-Back Pain Patients

Phase 3

Recruiting

• Conditions: Chronic Low-back Pain
• Interventions: Drug: HCP1004; Drug: RLD2401

• Registration Number: NCT06595004
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Study Start: 2024-11-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental 1	HCP1004	Take HCP1004 twice daily for 12 weeks orally.
Active Comparator	RLD2401	Take RLD2401 twice daily for 12 weeks orally.

Primary Outcome Measures

Name	Time	Method
Change from baseline in VAS	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in VAS(Visual Analog Scale)	8 weeks, 12 weeks
Change from baseline in ODI(Oswestry Disability Index) Score	4 weeks, 8 weeks, 12 weeks
Change from baseline in EQ-5D Score	4 weeks, 8 weeks, 12 weeks
Change from baseline in GSRS(Gastrointestinal Symptom-Rating Scale) Score	4 weeks, 8 weeks, 12 weeks
Usage of rescue medicine	4 weeks, 8 weeks, 12 weeks

Trial Locations

Locations (1)

Hanyang University Seoul Hospital; 🇰🇷 Seongdong-Gu, Seoul, Korea, Republic of