Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain
Phase 2
Completed
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT01015235
- Lead Sponsor
- KAI Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Placebo Placebo Placebo A2: KAI-1678 KAI-1678 Test Drug A3: Ketorolac Ketorolac Tromethamine Active Comparator
- Primary Outcome Measures
Name Time Method The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4). Post operative Day 1
- Secondary Outcome Measures
Name Time Method The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4) Post operative Day 1 The effect of KAI-1678 on pain intensity difference (PID) at 4 hours Post-operative Day 1 The effect of KAI-1678 on total quality analgesia Post-operative Day 1 The effect of KAI-1678 on time to meaningful pain relief Post-operative Day 1