Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain

A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion for the Treatment of Postoperative Pain

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.

Inclusion Criteria:

• American Society of Anesthesiologist (ASA) classification 1, 2, or 3
• total hip or total knee replacement
• pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)

Exclusion Criteria:

• presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment
• recent history of angina or myocardial infarction (MI)
• clinically significant abnormality on laboratory tests or electrocardiogram (ECG)