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A Randomized,Double Blind, Parallel Group, Placebo Controlled Dose Ranging Study to Assess the Analgesic Efficacy, Tolerability, Safety and Pharmacokinetic/Pharmacodynamic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging, placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post operative pain after undergoing third molar extraction.
Details
| Lead sponsor | Lotus Clinical Research, LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2014-07 |
| Completion | 2014-11 |
Conditions
- Pain
Interventions
- Placebo
- ketamine 25 mg
- ketamine 35 mg
- ketamine 50 mg
Primary outcomes
- Sum of Pain Intensity Difference — 3 hours
The primary objective of this study is to demonstrate the dose-response relationship for analgesia of three dose levels of ketamine sublingual wafer compared with placebo, using the summed pain intensity difference from baseline over the first 3 hours (SPID3) in subjects with acute moderate to severe pain following third molar extraction.
Countries
United States