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: December 17, 2013
Last verified: December 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ironwood Pharmaceuticals, Inc.:
Healthy subjects

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

ClinicalTrials.gov processed this record on October 23, 2014