A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
- Conditions
- Pain
- Interventions
- Registration Number
- NCT02199678
- Lead Sponsor
- Lotus Clinical Research, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ketamine 35 mg ketamine 35 mg ketamine Placebo Placebo Placebo ketamine 25 mg ketamine 25 mg ketamine ketamine 50 mg ketamine 50 mg ketamine
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Sum of Pain Intensity Difference 6 hours SPID 6
Safety and tolerability 6 hours Safety and tolerability of ketamine sublingual wafer as evaluated with physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs, and incidence of Adverse Events (AEs) and Serious AEs (SAEs)
Trial Locations
- Locations (2)
Prahealthsciences
🇺🇸Salt Lake City, Utah, United States
Lotus Clinical Research, LLC
🇺🇸Pasadena, California, United States