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NCT00531882 · ClinicalTrials.gov registry record · NA
Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers
A NA study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT00531882 is a NA study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 25 participants.
The verdict
NCT00531882, a NA study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
Inflammation clearly contributes to the progression of the cystic fibrosis (CF) lung disease, and administration of the anti-inflammatory agent high-dose ibuprofen retards the rate of decline of pulmonary function. However, utilization of this valuable drug has been suboptimal because of its rare, but dramatic, adverse effects. Therefore, alternative anti-inflammatory agents are urgently needed. One strategy for identifying new anti-inflammatory agents is to determine the mechanism by which the only proven anti-inflammatory agent for the CF lung disease, high-dose ibuprofen, exerts its effect. If this were known, then other drugs that act by a similar mechanism become candidates for treating the CF inflammatory disease. The investigators have shown, in our preliminary studies, that high dose ibuprofen limits the delivery of neutrophils to an inflamed mucosal surface, the gingival crevices. The investigators plan to test pioglitazone and simvastatin, (ibuprofen (positive control)) to determine their anti inflammatory affects on neutrophil migration to the oral mucosa. The hypothesis to be tested is that pioglitazone, and/or simvastatin will reduce neutrophils in the oral mucosa after 10 days of therapy in mouthwashes of healthy volunteers. Ibuprofen will be used as a positive control. This study will provide pilot data from healthy volunteers to support an FDA Grant to be submitted at a future date.
Interventions
- DRUG Ibuprofen
- DRUG Pioglitazone
- DRUG Simvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00531882
The ClinicalTrials.gov registry entry for NCT00531882 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ibuprofen is the first listed.
NCT00531882 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00531882 about?
NCT00531882 is a clinical study titled "Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers". Inflammation clearly contributes to the progression of the cystic fibrosis (CF) lung disease, and administration of the anti-inflammatory agent high-dose ibuprofen retards the rate of decline of pulmonary function. However, utilization of this valuable drug has been suboptimal because of its rare, b...
What is the current status of trial NCT00531882?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2007-09. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00531882?
The interventions under investigation include: Ibuprofen (DRUG), Pioglitazone (DRUG), Simvastatin (DRUG).
Who is sponsoring clinical trial NCT00531882?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
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