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NCT02199678 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
A Phase 2 study of Pain, sponsored by Lotus Clinical Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT02199678: Completed Phase 2 study of Pain, sponsored by Lotus Clinical Research.
NCT02199678 is a Phase 2 study of Pain that has completed, run by Lotus Clinical Research. The registered enrollment target is 120 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (61% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02199678, a Phase 2 study of Pain, has completed, sponsored by Lotus Clinical Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ketamine 25 mg
- DRUG ketamine 35 mg
- DRUG ketamine 50 mg
Study Locations (2)
California
- Lotus Clinical Research, LLC - Pasadena
Utah
- Prahealthsciences - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2014-07 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT02199678 record still lists
NCT02199678 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02199678 reports a single indexed study location in California, Utah.
Frequently Asked Questions
What is clinical trial NCT02199678 about?
NCT02199678 is a clinical study titled "A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction". 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.
What is the current status of trial NCT02199678?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2014-07. Estimated completion is 2014-11.
What conditions does trial NCT02199678 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT02199678?
The interventions under investigation include: Placebo (DRUG), ketamine 25 mg (DRUG), ketamine 35 mg (DRUG), ketamine 50 mg (DRUG).
Who is sponsoring clinical trial NCT02199678?
This trial is sponsored by Lotus Clinical Research, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02199678 being conducted?
This trial has 2 study locations across California, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02199678's enrollment target sits among peer trials
120 135th of 374 higher than 229 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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