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

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: IW-6118; Drug: Matching Placebo; Drug: Naproxen Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107236

ICP-109-201

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

IW-6118

Experimental group

Treatment:

Drug: IW-6118

Placebo

Placebo Comparator group

Treatment:

Drug: Matching Placebo

Naproxen Sodium

Active Comparator group

Treatment:

Drug: Naproxen Sodium