Conditions: Postoperative Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 192
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of MDT-10013 in men and women 18 to 80 years of age who are undergoing bunionectomy. The primary objective is to determine the analgesic efficacy of MDT-10013 compared with standard of care in the treatment of acute postoperative pain after subjects undergo bunionectomy.

Detailed description:

Arms:
arm 1: Subjects will receive MDT-10013. arm 2: Subjects will receive standard of care.

Interventions: intervention 1: MDT-10013 intervention 2: Standard of care for pain
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: