Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 30 |
| Updated: | 3/3/2019 |
| Start Date: | June 2010 |
| End Date: | August 2010 |
A Phase 2, Single-center, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Study of a Single Dose of IW-6118, in Patients Undergoing Third Molar Extraction
The purpose of this study is to assess the safety of IW-6118 when administered as a single
oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an
exploratory manner.
oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an
exploratory manner.
Inclusion Criteria:
- Between 18 and 30 years old at time of screening;
- BMI > 18.5 and < 30.0;
- In overall good health with no clinically-significant laboratory, ECG, or physical
exam findings;
- Patient requires two ipsilateral third molar extractions of which one must be a full
or partial bony mandibular impaction;
- Women of childbearing potential must have a negative pregnancy test and must agree to
use double-barrier contraception;
- Other inclusion criteria per protocol.
Exclusion Criteria:
- History of any clinically-significant medical condition;
- Previous usage of prescription, OTC, or investigational drugs as per protocol
requirements;
- Inadequate levels of pain to be included in the study;
- Other exclusion criteria per protocol.
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