NCT02356965

Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: iX Biopharma Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Ketamine	Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.
DRUG	Placebo (for Ketamine)	Sublingual sugar pill developed to mimic ketamine sublingual dose.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2015-02-06
• Last updated: 2015-03-26

Locations

1 site across 1 country: United States