NCT01107236CompletedPhase 2
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
Ironwood Pharmaceuticals, Inc.1 site in 1 country90 target enrollmentStarted: June 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Safety Assessments
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
IW-6118
Experimental
Intervention: IW-6118 (Drug)
Placebo
Placebo Comparator
Intervention: Matching Placebo (Drug)
Naproxen Sodium
Active Comparator
Intervention: Naproxen Sodium (Drug)
Outcomes
Primary Outcomes
Safety Assessments
Time Frame: Duration of the Study
Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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