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NCT02131545 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine
A Phase 1 study of Dementia and Delirium, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02131545 is a Phase 1 study of Dementia and Delirium that has completed, run by Mayo Clinic. The registered enrollment target is 10 participants, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02131545, a Phase 1 study of Dementia and Delirium, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Quetiapine, a second generation antipsychotic, is only available as oral tablets. However, topical and rectal formulations have been produced in compounding pharmacies. There is no data available suggesting that topical or rectal formulations provide serum levels similar to oral medication. In the clinical setting, when oral administration of quetiapine is not possible (for example, when a patient is extremely ill physically or mentally or both), clinicians and pharmacists have collaborated in such cases and have at times had to administer quetiapine compounded in other dosage formulations such as rectal or topical formulations. Despite clinical effectiveness of these other formulations, there are no available studies that have investigated blood levels of the drug other than the oral form. The investigators are therefore designing this pharmacokinetic study to evaluate the the systemic absorption of quetiapine in oral, rectal and topical formulations. If the investigators are able to demonstrate detectable levels from rectal and topical quetiapine formulations compared to the oral form, this knowledge will enhance clinical psychiatric practice by providing a more broad route of administration for quetiapine which is a commonly used drug for psychiatric symptoms.
Interventions
- DRUG Quetiapine 25 mg gel applied topically
- DRUG Quetiapine 25 mg tablet by mouth
- DRUG Quetiapine 25 mg rectal suppository
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02131545
The ClinicalTrials.gov registry entry for NCT02131545 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 3 interventions - of which Quetiapine 25 mg gel applied topically is the first listed.
NCT02131545 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT02131545 about?
NCT02131545 is a clinical study titled "Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine". Quetiapine, a second generation antipsychotic, is only available as oral tablets. However, topical and rectal formulations have been produced in compounding pharmacies. There is no data available suggesting that topical or rectal formulations provide serum levels similar to oral medication. In the c...
What is the current status of trial NCT02131545?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-06. Estimated completion is 2016-07.
What conditions does trial NCT02131545 study?
This clinical trial studies the following conditions: Dementia, Delirium.
What interventions are being tested in trial NCT02131545?
The interventions under investigation include: Quetiapine 25 mg gel applied topically (DRUG), Quetiapine 25 mg tablet by mouth (DRUG), Quetiapine 25 mg rectal suppository (DRUG).
Who is sponsoring clinical trial NCT02131545?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02131545 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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