Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
Phase 2
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01107236
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IW-6118 IW-6118 - Placebo Matching Placebo - Naproxen Sodium Naproxen Sodium -
- Primary Outcome Measures
Name Time Method Safety Assessments Duration of the Study Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ironwood Investigational Site
🇺🇸Salt Lake City, Utah, United States