clinical trial for the patients with degenerative disc disease
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0001037
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1)Degenerative disc disease patients of aged over 20 years
2)Appropriate for the study by physical examination, laboratory tests, interview
3)Have one or more of the symptomatic lumbar level(L1~S1) as confirmed using radiology(X-ray, MRI and/or discogram/CT)
4)Have signed a written informed consent voluntarily, prior to the any procedure
1)Subjects unable to have radiological examination
2)Have history of neurological disease
3)Sacroiliac joint dysfunction
4)Have been treated with any drugs for pain control within 7 days prior to the first administration
5)Pregnant women, nursing mothers or subjects who do not agree to assigned contraception in the study
6)Participated in any other clinical trials within 30 days prior to the first administration
7)Other clinically significant disgnosis not to include by investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method investigate the safety and tolerability for 12wks after the single disc injection of YH14618
- Secondary Outcome Measures
Name Time Method ODI(oswestry disability index) change in comparison with the baseline for 12wks after the single injection ;pain score of VAS(visual analogue scale) in comparison with the baseline for 12wks after the single injection