NCT02199678

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 21, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

July 23, 2014

Last Update Submit

November 19, 2014

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Sum of Pain Intensity Difference

    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.

    3 hours

Secondary Outcomes (2)

  • Sum of Pain Intensity Difference

    6 hours

  • Safety and tolerability

    6 hours

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

ketamine 25 mg

ACTIVE COMPARATOR

ketamine

Drug: ketamine 25 mg

ketamine 35 mg

ACTIVE COMPARATOR

ketamine

Drug: ketamine 35 mg

ketamine 50 mg

ACTIVE COMPARATOR

ketamine

Drug: ketamine 50 mg

Interventions

PlaceboDRUG

placebo

Placebo
ketamine 25 mgDRUG

ketamine

ketamine 25 mg
ketamine 35 mgDRUG

ketamine

ketamine 35 mg
ketamine 50 mgDRUG

ketamine

ketamine 50 mg

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
18- 38 years of age 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 (2)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

Prahealthsciences

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

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

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 24, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 21, 2014

Record last verified: 2014-07

Locations

US(2)