Trials / Completed
CompletedNCT02199678
A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
A Randomized,Double Blind, Parallel Group, Placebo Controlled Dose Ranging Study to Assess the Analgesic Efficacy, Tolerability, Safety and Pharmacokinetic/Pharmacodynamic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Lotus Clinical Research, LLC · Academic / Other
- Sex
- All
- Age
- 18 Years – 38 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | placebo |
| DRUG | ketamine 25 mg | ketamine |
| DRUG | ketamine 35 mg | ketamine |
| DRUG | ketamine 50 mg | ketamine |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2014-07-24
- Last updated
- 2014-11-21
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02199678. Inclusion in this directory is not an endorsement.