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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01107236
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : December 19, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: IW-6118 Drug: Matching Placebo Drug: Naproxen Sodium Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2010
Actual Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IW-6118 Drug: IW-6118
Single dose

Placebo Comparator: Placebo Drug: Matching Placebo
Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium

Active Comparator: Naproxen Sodium Drug: Naproxen Sodium
Single dose

Primary Outcome Measures :
  1. Safety Assessments [ Time Frame: Duration of the Study ]
    Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01107236

United States, Utah
Ironwood Investigational Site
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.

Responsible Party: Ironwood Pharmaceuticals, Inc. Identifier: NCT01107236     History of Changes
Other Study ID Numbers: ICP-109-201
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Ironwood Pharmaceuticals, Inc.:
Healthy subjects

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action