Study Testing a Pain Medication After Wisdom Tooth Extraction
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 38 |
| Updated: | 3/16/2015 |
| Start Date: | December 2014 |
| End Date: | February 2015 |
| Contact: | Georgia Simmons, BSN |
| Email: | georgia.simmons@ixbiopharma.com |
| Phone: | +1-801-694-7846 |
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
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.
tongue) wafer against placebo to see how effective the medication is to treat moderate to
severe pain after wisdom tooth extraction.
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.
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.
Healthy male and female subjects, ages 18-38 years old, who are scheduled to undergo two
ipsilateral third molar extractions.
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