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

Completed · Phase 2 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01107236

Run by

Ironwood Pharmaceuticals, Inc.

People needed

90

Starts

2010-06-01

Expected to finish

2010-08-01

Last updated by the study team

2022-08-11

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ironwood Investigational Site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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