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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01107236

Enrollment

Registered

2010-04-20

Start date

2010-06-30

Completion date

2010-08-31

Last updated

2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy subjects

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.

Interventions

DRUGIW-6118

Single dose

DRUGMatching Placebo

Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium

DRUGNaproxen Sodium

Single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Safety Assessments	Duration of the Study	Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026