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Sponsors and Collaborators: |
Oregon Health and Science University Merck |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00939302 |
The purpose of this study is to test the safety and effectiveness of fosaprepitant. The investigators want to find out what effects, good and/or bad, it has on chemotherapy induced nausea and vomiting that occurs despite the best nausea prevention measures.
Condition | Intervention | Phase |
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Breakthrough Chemotherapy Induced Nausea and Vomiting |
Drug: fosaprepitant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting |
Estimated Enrollment: | 40 |
Study Start Date: | September 2009 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Fosaprepitant: Experimental |
Drug: fosaprepitant
150 mg IV once at time of subject breakthrough CINV
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joseph Bubalo, PharmD | 503-494-1054 | bubaloj@ohsu.edu |
Contact: Richard T Maziarz, MD | 503-494-1551 | maziarzr@ohsu.edu |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Joseph Bubalo, PharmD | Oregon Health and Science University |
Responsible Party: | Oregon Health & Science University ( Joseph Bubalo, PharmD ) |
Study ID Numbers: | HEM-08053-L |
Study First Received: | July 13, 2009 |
Last Updated: | July 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00939302 History of Changes |
Health Authority: | United States: Food and Drug Administration |
breakthrough CINV fosaprepitant |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Antiemetics |
Nausea Peripheral Nervous System Agents Aprepitant |
Vomiting Signs and Symptoms, Digestive Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Pharmacologic Actions Signs and Symptoms |
Autonomic Agents Therapeutic Uses Nausea Peripheral Nervous System Agents Central Nervous System Agents Aprepitant |