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Completed

NCT Number: NCT01107236

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

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.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ironwood Investigational Site

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IW-6118

Drug

Single dose

Matching Placebo

Drug

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

Naproxen sodium

Drug

Single dose

Primary outcomes

  1. Safety Assessments

    Time frame: Duration of the Study

    Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.

Sponsors and collaborators

Lead sponsor

Ironwood Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 20, 2010
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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