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NCT01596400 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years
A Phase 1 study of Chemotherapy-induced Nausea and Vomiting, sponsored by Kyowa Kirin Pharmaceutical Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 12
- Study locations
NCT01596400: Completed Phase 1 study of Chemotherapy-induced Nausea and Vomiting, sponsored by Kyowa Kirin Pharmaceutical Development.
NCT01596400 is a Phase 1 study of Chemotherapy-induced Nausea and Vomiting that has completed, run by Kyowa Kirin Pharmaceutical Development. The registered enrollment target is 19 participants, below the 443-participant average among 3 other Chemotherapy-induced Nausea and Vomiting trials with a reported enrollment target (96% lower). The trial reports 12 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596400, a Phase 1 study of Chemotherapy-induced Nausea and Vomiting, has completed, sponsored by Kyowa Kirin Pharmaceutical Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.
Primary Outcome
Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.
Conditions Studied
Interventions
- DRUG granisetron transdermal system
- DRUG Granisetron IV
Study Locations (12)
Florida
- University of Florida - Gainesville
- Nemours Children's Clinic - Jacksonville
- University of South Florida - Tampa
California
- David Geffen School of Medicine at UCLA - Los Angeles
- Children's Hospital of Orange County - Orange
Texas
- UTSW/Childrens Medical Center - Dallas
- UT Southwestern Medical Center - Dallas
Washington
- Providence Sacred Heart Medical Center and Children's Hospital - Spokane
- Madigan Army Medical Center - Tacoma
Colorado
- Children's Hospital Colorado, Center for Cancer and Blood Disorders - Aurora
Mississippi
- University of Mississippi Medical Center - Jackson
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT01596400 record still lists
NCT01596400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 443-participant average among 3 other Chemotherapy-induced Nausea and Vomiting trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Chemotherapy-induced Nausea and Vomiting appearing as the primary indexed condition, and to 2 interventions - of which granisetron transdermal system is the first listed.
NCT01596400 lists 12 locations in 7 states (Florida, California, Texas).
Frequently Asked Questions
What is clinical trial NCT01596400 about?
NCT01596400 is a clinical study titled "Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years". The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.
What is the current status of trial NCT01596400?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-05. Estimated completion is 2016-12.
What conditions does trial NCT01596400 study?
This clinical trial studies the following conditions: Chemotherapy-induced Nausea and Vomiting.
What interventions are being tested in trial NCT01596400?
The interventions under investigation include: granisetron transdermal system (DRUG), Granisetron IV (DRUG).
Who is sponsoring clinical trial NCT01596400?
This trial is sponsored by Kyowa Kirin Pharmaceutical Development, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01596400 being conducted?
This trial has 12 study locations across California, Colorado, Florida, Mississippi, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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