Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Treatments: Naproxen

Criteria

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.