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Completed

NCT Number: NCT02199678

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lotus Clinical Research, LLC, Pasadena, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

18- 38 years of age Scheduled to undergo two ipsilateral third molar extractions

Treatment and study plan

Placebo

Drug

placebo

ketamine 25 mg

Drug

ketamine

ketamine 35 mg

Drug

ketamine

ketamine 50 mg

Drug

ketamine

Primary outcomes

  1. Sum of Pain Intensity Difference

    Time frame: 3 hours

    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.

Secondary outcomes

  1. Sum of Pain Intensity Difference

    Time frame: 6 hours

    SPID 6

  2. Safety and tolerability

    Time frame: 6 hours

    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)

Sponsors and collaborators

Lead sponsor

Lotus Clinical Research, LLC

Other

Collaborators

  • iX Biopharma Ltd.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2014
Registry last updated
Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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