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
Overview
- Phase
- Phase 2
- Intervention
- Ketamine
- Conditions
- Pain
- Sponsor
- iX Biopharma Ltd.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Sum of Pain Intensity Difference
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of the study is to test two different doses of ketamine sub-lingual (under the tongue) wafer against placebo to see how effective the medication is to treat moderate to severe pain after wisdom tooth extraction.
Detailed Description
This is a Phase 2, randomized, double-blind, parallel group, 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. The study will enroll approximately 80 subjects at a single site. Subjects will be at least 18 years to 38 years of age. Subjects will receive a single dose of 70 mg or 100 mg sublingual ketamine wafer or placebo. Efficacy assessment will include pain intensity, use of rescue medication, and Patient Global Assessment (PGA) of pain control. Safety assessments will include monitoring of AEs and SAEs, clinical laboratory tests, vital sign measurements, oral assessments, and ECGs. A maximum of eight 4ml blood samples will be taken from each participant up to 8 hours after study drug administration for plasma analysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ketamine 70 mg Sublingual Wafer
Single dose of 70 mg ketamine sublingual wafer
Intervention: Ketamine
Ketamine 100 mg Sublingual Wafer
Single dose of 100 mg ketamine sublingual wafer
Intervention: Ketamine
Placebo
Single dose of placebo sublingual wafer
Intervention: Placebo (for Ketamine)
Outcomes
Primary Outcomes
Sum of Pain Intensity Difference
Time Frame: 3 hours
Demonstrate the dose-response relationship for analgesia of two 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 Outcomes
- Sum of Pain Intensity Difference(6 hours)
- Safety and Tolerability evaluated by physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs and Incident of Adverse Events (AEs) and Serious Adverse Events (SAEs).(8 hours)