drugset / Trial / NCT03838133
A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult subjects following bunionectomy.
Timeline
- Start
- 2019-03-05
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 50 mg | — |
| Comparator | Ropivacaine | Other / unclassified | 50 mg | Other |
| Subject | TLC590 | Unknown | 152 mg | Other |
| Subject | TLC590 | Unknown | 190 mg | Other |
| Subject | TLC590 | Unknown | 228 mg | Other |