A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199678
• Other study ID #: KET003
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2014
• Last updated: November 19, 2014
• Start date: July 2014
• Est. completion date: November 2014

Study information

• Verified date: July 2014
• Source: Lotus Clinical Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 38 Years
• Eligibility: 18- 38 years of age Scheduled to undergo two ipsilateral third molar extractions

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Placebo
placebo
• ketamine 25 mg
ketamine
• ketamine 35 mg
ketamine
• ketamine 50 mg
ketamine

Locations

Country	Name	City	State
United States	Lotus Clinical Research, LLC	Pasadena	California
United States	Prahealthsciences	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Lotus Clinical Research, LLC	iX Biopharma Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of Pain Intensity Difference	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.	3 hours	No
Secondary	Sum of Pain Intensity Difference	SPID 6	6 hours	No
Secondary	Safety and tolerability	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)	6 hours	Yes