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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01107236
First received: April 19, 2010
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: IW-6118
Drug: Matching Placebo
Drug: Naproxen Sodium
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ironwood Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety Assessments [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.


Enrollment: 90
Study Start Date: June 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107236

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

No publications provided

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01107236     History of Changes
Other Study ID Numbers: ICP-109-201
Study First Received: April 19, 2010
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ironwood Pharmaceuticals, Inc.:
Healthy subjects

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

ClinicalTrials.gov processed this record on May 16, 2013