drugset / Trial / NCT04673461
Study Investigating STA363 Compared to Placebo in Patients With Chronic Discogenic Low Back Pain
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands.
Timeline
- Start
- 2020-07-31
- Primary completion
- 2023-09-01
- Completion
- 2023-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lactic Acid | Other / unclassified | 90 mg | Other |
| Subject | Lactic Acid | Other / unclassified | 180 mg | Other |