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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02199678
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
iX Biopharma Ltd.
Information provided by (Responsible Party):
Lotus Clinical Research, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Placebo Drug: ketamine 25 mg Drug: ketamine 35 mg Drug: ketamine 50 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
placebo

Active Comparator: ketamine 25 mg
ketamine
Drug: ketamine 25 mg
ketamine

Active Comparator: ketamine 35 mg
ketamine
Drug: ketamine 35 mg
ketamine

Active Comparator: ketamine 50 mg
ketamine
Drug: ketamine 50 mg
ketamine




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
18- 38 years of age Scheduled to undergo two ipsilateral third molar extractions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199678


Locations
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United States, California
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
United States, Utah
Prahealthsciences
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Lotus Clinical Research, LLC
iX Biopharma Ltd.

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Responsible Party: Lotus Clinical Research, LLC
ClinicalTrials.gov Identifier: NCT02199678     History of Changes
Other Study ID Numbers: KET003
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action