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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00108095 |
This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV
Condition | Intervention | Phase |
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Postoperative Nausea and Vomiting |
Drug: intravenous ondansetron |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 665 |
Study Start Date: | October 2004 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NKT102260 |
Study First Received: | April 13, 2005 |
Last Updated: | May 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00108095 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
nausea vomiting emesis PONV post operative nausea and vomiting |
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 |
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 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 |