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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.
ClinicalTrials.gov Identifier: NCT01107236
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : December 19, 2013
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

April 19, 2010
April 20, 2010
December 19, 2013
June 2010
August 2010   (Final data collection date for primary outcome measure)
Safety Assessments [ Time Frame: Duration of the Study ]
Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.
Pain Intensity [ Time Frame: Three hours post-dose ]
Measured on a 0-100 VAS Scale (0=no pain, 100=very severe pain)
Complete list of historical versions of study NCT01107236 on ClinicalTrials.gov Archive Site
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Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • 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
  • Experimental: IW-6118
    Intervention: Drug: IW-6118
  • Placebo Comparator: Placebo
    Intervention: Drug: Matching Placebo
  • Active Comparator: Naproxen Sodium
    Intervention: Drug: Naproxen Sodium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
Same as current
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August 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 30 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01107236
ICP-109-201
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Ironwood Pharmaceuticals, Inc.
Ironwood Pharmaceuticals, Inc.
Not Provided
Not Provided
Ironwood Pharmaceuticals, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP