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RECRUITING
NCT07858734
PHASE2

Postsurgical Analgesia After Unilateral Bunionectomy

Sponsor: AmacaThera Inc.

View on ClinicalTrials.gov

Summary

The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of AMT-143 for Postsurgical Analgesia After Unilateral Bunionectomy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-10-18

Completion Date

2027-06-15

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DRUG

AMT-143

Group 1 will receive AMT-143 containing 354 mg ropivacaine.

DRUG

AMT-143

Group 2 will receive AMT-143 containing 707 mg ropivacaine.

OTHER

Saline (NaCl 0,9 %) (placebo)

Group 3 will receive 2.00 mL Placebo \[sodium chloride (NaCl) 0.9%\].

Locations (1)

Diex Reserche

Sherbrooke, Quebec, Canada