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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00619359 |
The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 (fosaprepitant dimeglumine) to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.
Condition | Intervention | Phase |
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Chemotherapy-Induced Nausea and Vomiting (CINV) |
Drug: fosaprepitant dimeglumine Drug: Aprepitant Drug: Comparator: Placebo (unspecified) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability & Efficacy of a Single Dose of Intravenous MK0517 (Fosaprepitant Dimeglumine) for Prevention of Chemotherapy-Induced Nausea & Vomiting Associated With Cisplatin Chemo |
Estimated Enrollment: | 2292 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Arm 1: study medication + Pbo
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Drug: fosaprepitant dimeglumine
single IV dose of 150 mg of fosaprepitant dimeglumine.
Drug: Comparator: Placebo (unspecified)
3-day oral Pbo dosing regimen of aprepitant.
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2: Active Comparator
Arm 2: Active comparator + Pbo
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Drug: Aprepitant
Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).
Drug: Comparator: Placebo (unspecified)
single Pbo IV dose of fosaprepitant dimeglumine.
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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: Toll Free Number | 1-888-577-8839 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_594, MK0517-017 |
Study First Received: | January 28, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00619359 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Vomiting Cisplatin |
Signs and Symptoms, Digestive Nausea Aprepitant |
Autonomic Agents Therapeutic Uses Physiological Effects of Drugs Gastrointestinal Agents |
Antiemetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |