Trials / Recruiting
RecruitingNCT07222748
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
A Phase 3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- TLC Biopharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TLC590 | TLC590 (Ropivacaine Extended-Release Injectable Suspension) |
| DRUG | Liposomal Bupivacaine | Bupivacaine Liposome Injectable Suspension |
| DRUG | Saline Placebo | Normal Saline 0.9% |
Timeline
- Start date
- 2025-11-17
- Primary completion
- 2026-04-01
- Completion
- 2026-05-01
- First posted
- 2025-10-30
- Last updated
- 2025-12-02
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07222748. Inclusion in this directory is not an endorsement.