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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: IW-6118; Drug: Matching Placebo; Drug: Naproxen Sodium

• Registration Number: NCT01107236
• Lead Sponsor: Ironwood Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Study Start: 2010-06
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2022-08
• Disposition First Submitted: 2022-08-09
• Disposition First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-09
• Disposition First Posted: 2022-08-11
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IW-6118	IW-6118	-
Placebo	Matching Placebo	-
Naproxen Sodium	Naproxen Sodium	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ironwood Investigational Site; 🇺🇸 Salt Lake City, Utah, United States