Who is sponsoring NCT02356965?

NCT02356965 is sponsored by iX Biopharma Ltd..

What drugs are being tested in NCT02356965?

Interventions: Ketamine, Placebo (for Ketamine).

What is the status of NCT02356965?

NCT02356965 is currently COMPLETED.

Last reviewed 2015-03-24 · How we verify

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

NCT02356965 Phase 2 COMPLETED

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.

Details

Lead sponsor	iX Biopharma Ltd.
Phase	Phase 2
Status	COMPLETED
Enrolment	80
Start date	2014-12
Completion	2015-02

Conditions

Pain

Interventions

Ketamine
Placebo (for Ketamine)

Primary outcomes

Sum of Pain Intensity Difference — 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.

Countries

United States