drugset / Trial / NCT02242435
A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.
Timeline
- Start
- 2014-09
- Primary completion
- 2015-04
- Completion
- 2015-05
Outcome
Missed primary endpoint
registry analysis (superiority test); Ampion 4 mL Injection vs Placebo 4 mL Injection; p = 0.26; ANCOVA; note: Adjusted for baseline WOMAC score. NCT02242435 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASPARTYL-ALANYL-DIKETOPIPERAZINE | Protein / enzyme biologic | 4 ml | Other |