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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: IW-6118; Drug: Matching Placebo; Drug: Naproxen Sodium

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Matching Placebo; Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium
EXPERIMENTAL: IW-6118	Drug: IW-6118; Single dose
ACTIVE_COMPARATOR: Naproxen Sodium	Drug: Naproxen Sodium; Single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessments	Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.	Duration of the Study

Collaborators and Investigators

• Sponsor: Ironwood Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (ESTIMATE): April 20, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Healthy subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: ICP-109-201