NCT02356965

Brief Summary

The purpose of the study is to test two different doses of ketamine sub-lingual (under the tongue) wafer against placebo to see how effective the medication is to treat moderate to severe pain after wisdom tooth extraction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

January 29, 2015

Last Update Submit

March 24, 2015

Conditions

Pain

Keywords

Third molar extractionWisdom tooth extraction

Outcome Measures

Primary Outcomes (1)

  • Sum of Pain Intensity Difference

    Demonstrate the dose-response relationship for analgesia of two 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

Secondary Outcomes (2)

  • Sum of Pain Intensity Difference

    6 hours

  • Safety and Tolerability evaluated by physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs and Incident of Adverse Events (AEs) and Serious Adverse Events (SAEs).

    8 hours

Study Arms (3)

Ketamine 70 mg Sublingual Wafer

EXPERIMENTAL

Single dose of 70 mg ketamine sublingual wafer

Drug: Ketamine

Ketamine 100 mg Sublingual Wafer

EXPERIMENTAL

Single dose of 100 mg ketamine sublingual wafer

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Single dose of placebo sublingual wafer

Drug: Placebo (for Ketamine)

Interventions

KetamineDRUG

Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.

Ketamine 100 mg Sublingual WaferKetamine 70 mg Sublingual Wafer
Placebo (for Ketamine)DRUG

Sublingual sugar pill developed to mimic ketamine sublingual dose.

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Healthy male and female subjects, ages 18-38 years old, who are scheduled to undergo two ipsilateral third molar extractions.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain

Interventions

KetamineSugars

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCarbohydrates

Study Officials

  • Derek D Muse, MD

    Jean Brown Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 6, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(1)