JPRN-jRCT2031230145RecruitingPhase 2
A Phase II, Multicenter, Double-blind, Randomized, Placebo-controlled, Clinical study Evaluating the Efficacy, Safety and Tolerability of a Targeted Single Injection of an Intradiscal AMG0103 in Subjects with Chronic Discogenic Lumber Back Pain
Sakai Daisuke0 sites92 target enrollmentStarted: June 16, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 92
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to <= 75age old (—)
- Sex
- All
Inclusion Criteria
- •*Patients with chronic low back pain for at least 3 months, where back pain is greater than hip pain and leg pain/
- •*Patients with low back pain NRS score of at least 4 or more and 9 or less at the screening period and at the Visit 1 (average of two NRS score over a 24 hour period).
Exclusion Criteria
- •*Patients with a history of an endocrine or metabolic bone disorder, rheumatoid arthritis that affects the spine. Undergoing dialysis.
- •*Patients with previous invasive treatments affecting the intervertebral disc.
Investigators
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