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

Lotus Clinical Research

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: ketamine 50 mg; Drug: ketamine 25 mg; Drug: ketamine 35 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02199678

KET003

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

ketamine 25 mg

Active Comparator group

Description:

ketamine

Treatment:

Drug: ketamine 25 mg

ketamine 35 mg

Active Comparator group

Description:

ketamine

Treatment:

Drug: ketamine 35 mg

ketamine 50 mg

Active Comparator group

Description:

ketamine

Treatment:

Drug: ketamine 50 mg