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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01107236 |
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Date of registration:
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19/04/2010 |
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Primary sponsor: |
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Public title:
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Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
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Scientific title:
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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 |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01107236 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: IW-6118
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Drug: Matching Placebo
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Drug: Naproxen Sodium
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Primary Outcome(s)
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Safety Assessments
[Time Frame: Duration of the Study]
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Secondary ID(s)
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ICP-109-201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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