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Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction

NCT01107236 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-08-11

No results posted yet for this study

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

  • Healthy

Interventions

DRUG

IW-6118

Single dose

DRUG

Matching Placebo

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

DRUG

Naproxen Sodium

Single dose

Sponsors & Collaborators

  • Ironwood Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107236 on ClinicalTrials.gov