Evaluating CKD-981 for knee osteoarthritis symptom relief
A Randomized, Double-blind, Sham-controlled, Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981 in Patients With Degenerative Knee Osteoarthritis
This study is testing if a new treatment called CKD-981 can help relieve knee pain in people aged 40 to 80 with mild to moderate osteoarthritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Chong Kun Dang Pharmaceutical Industry-sponsored |
| Locations | 1 site (Wonju) |
| Trial ID | NCT06954766 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the safety and temporary symptom improvement efficacy of CKD-981 in patients suffering from mild to moderate knee osteoarthritis. Participants will be individuals aged 40 to 80 who have experienced knee pain for over eight weeks, with specific severity criteria. The study will involve administering CKD-981, a sham device, a reference drug, and a placebo to evaluate their effects on pain relief. The primary focus is to determine whether CKD-981 can provide significant symptom relief compared to the control treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 to 80 with mild to moderate knee osteoarthritis and significant pain lasting more than eight weeks.
Not a fit: Patients with previous knee surgery on the affected side or those with other specific joint diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients with knee osteoarthritis, potentially improving their quality of life.
How similar studies have performed: While this approach is being evaluated in this pilot study, similar interventions have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between 40 years and 80 years old * Patients who have experiencing knee pain more than 8 weeks * VAS more than 40 mm * Kellgren and Lawrence grade 2 and 3 in X' ray knee joint Exclusion Criteria: * Previous knee surgery in affected side * Patients with Rheumatoid arthritis, connective tissue disease, Paget's disease * Infection of knee joint * BMI more than 35kg/m2
Where this trial is running
Wonju
- Wonju Severance Christian Hospital — Wonju, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Sung Hoon KIm, M.D, Ph.D
- Email: kimrehab@yonsei.ac.kr
- Phone: 033-741-0114
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.