Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
NCT ID: NCT01107236
Last Updated: 2022-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2010-06-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IW-6118
IW-6118
Single dose
Placebo
Matching Placebo
Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium
Naproxen Sodium
Naproxen Sodium
Single dose
Interventions
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IW-6118
Single dose
Matching Placebo
Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium
Naproxen Sodium
Single dose
Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* Previous usage of prescription, OTC, or investigational drugs as per protocol requirements;
* Inadequate levels of pain to be included in the study;
18 Years
30 Years
ALL
Yes
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Ironwood Investigational Site
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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ICP-109-201
Identifier Type: -
Identifier Source: org_study_id
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