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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00090155 |
The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.
Condition | Intervention | Phase |
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Postoperative Nausea and Vomiting |
Drug: MK0869, aprepitant Drug: Comparator: ondansetron IV |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomiting |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_011, MK0869-090 |
Study First Received: | August 24, 2004 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00090155 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Postoperative Nausea and Vomiting Neurotransmitter Agents Tranquilizing Agents Vomiting Signs and Symptoms, Digestive Psychotropic Drugs Central Nervous System Depressants Antiemetics Antipsychotic Agents |
Serotonin Signs and Symptoms Postoperative Complications Antipruritics Anti-Anxiety Agents Nausea Ondansetron Peripheral Nervous System Agents Aprepitant |
Neurotransmitter Agents Vomiting Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Antiemetics Signs and Symptoms Serotonin Antagonists Pathologic Processes Therapeutic Uses Antipruritics Nausea Ondansetron |
Dermatologic Agents Aprepitant Postoperative Nausea and Vomiting Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Serotonin Agents Postoperative Complications Autonomic Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |