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CompletedNCT01107236Updated Aug 11, 2022

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

A Phase 2 interventional study of IW-6118 and Matching Placebo in Healthy, sponsored by Ironwood Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-11.

Sponsored by Ironwood Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy subjects
03

In context

Lead sponsor

Ironwood Pharmaceuticals, Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    IW-6118

    Drug: IW-6118

  • Placebo comparator
    Placebo

    Drug: Matching Placebo

  • Active comparator
    Naproxen Sodium

    Drug: Naproxen Sodium

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

06

What researchers measure

Primary outcomes

  1. Safety Assessments

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

    Time frame: Duration of the Study

07

Study locations

1 site
  • Ironwood Investigational Site
    Salt Lake City, Utah 84124, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01107236
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Apr 20, 2010
Start date
Jun 2010
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Aug 11, 2022
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Ironwood Pharmaceuticals, Inc.

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