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

NCT ID: NCT02199678

Last Updated: 2014-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

ketamine 25 mg

ketamine

Group Type ACTIVE_COMPARATOR

ketamine 25 mg

Intervention Type DRUG

ketamine

ketamine 35 mg

ketamine

Group Type ACTIVE_COMPARATOR

ketamine 35 mg

Intervention Type DRUG

ketamine

ketamine 50 mg

ketamine

Group Type ACTIVE_COMPARATOR

ketamine 50 mg

Intervention Type DRUG

ketamine

Interventions

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Placebo

placebo

Intervention Type DRUG

ketamine 25 mg

ketamine

Intervention Type DRUG

ketamine 35 mg

ketamine

Intervention Type DRUG

ketamine 50 mg

ketamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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iX Biopharma Ltd.

OTHER

Sponsor Role collaborator

Lotus Clinical Research, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lotus Clinical Research, LLC

Pasadena, California, United States

Site Status

Prahealthsciences

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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KET003

Identifier Type: -

Identifier Source: org_study_id