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Trials / Completed

CompletedNCT01107236

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
Phase
Phase 2
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Ironwood Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGIW-6118Single dose
DRUGMatching PlaceboSingle dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium
DRUGNaproxen SodiumSingle dose

Timeline

Start date
2010-06-01
Primary completion
2010-08-01
Completion
2010-08-01
First posted
2010-04-20
Last updated
2022-08-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01107236. Inclusion in this directory is not an endorsement.

Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction (NCT01107236) · Clinical Trials Directory