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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: |
NCT00531882 |
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Date of registration:
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18/09/2007 |
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Primary sponsor: |
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Public title:
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Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers
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Scientific title:
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A Pilot Study Evaluating the Effect of Pioglitazone, Simvastatin, and Ibuprofen on Neutrophil Migration in Vivo in Healthy Subjects |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00531882 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Kathleen A Hilliard, BA, CCRC |
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Address:
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Telephone:
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216-844-7489 |
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Email:
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kathleen.hilliard@case.edu |
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Affiliation:
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Name:
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Kathleen A Hilliard, BA, CCRC |
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Address:
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Telephone:
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216.844.7489 |
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Email:
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kathleen.hilliard@case.edu |
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Affiliation:
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Name:
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Michael W Konstan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospitals of Cleveland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- = 18 < 50 years of age
- Healthy volunteers must be in general good health as determined by a medical
history.
- Ability to understand and sign the informed consent form
- Ability to adhere to the protocol.
- Willing to use an acceptable form of birth control
Exclusion Criteria:
- History of diabetes requiring insulin
- The use of NSAIDS (ibuprofen) or corticosteroids including inhaled steroids. Nasal
steroids are acceptable.
- The use of statin lowering medications
- Active gingival disease (Active tooth or gum disease)
- Any chronic inflammatory condition that immuno compromises the volunteer as
determined by medical history.
- Pregnant or planning to become pregnant
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anti Inflammatory Non-Steroidal
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Cystic Fibrosis
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Neutrophils
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Intervention(s)
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Drug: Ibuprofen
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Drug: Pioglitazone
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Drug: Simvastatin
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Primary Outcome(s)
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Neutrophil delivery to the oral mucosa using a noninvasive mouth wash technique
[Time Frame: 3x before treatment, 3x during treatment and 3x post treatment]
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Secondary ID(s)
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Pilot Healthy Volunteers
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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