Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 healthy
Started Jun 2010
Shorter than P25 for phase_2 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedAugust 11, 2022
August 1, 2022
2 months
April 19, 2010
August 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Assessments
Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.
Duration of the Study
Study Arms (3)
IW-6118
EXPERIMENTALPlacebo
PLACEBO COMPARATORNaproxen Sodium
ACTIVE COMPARATORInterventions
Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium
Eligibility Criteria
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;
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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ironwood Investigational Site
Salt Lake City, Utah, 84124, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 20, 2010
Study Start
June 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 11, 2022
Record last verified: 2022-08