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

NCT02199678 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-11-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Placebo

placebo

DRUG

ketamine 25 mg

ketamine

DRUG

ketamine 35 mg

ketamine

DRUG

ketamine 50 mg

ketamine

Sponsors & Collaborators

  • iX Biopharma Ltd.

    collaborator OTHER

  • Lotus Clinical Research, LLC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02199678 on ClinicalTrials.gov