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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: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00108095 |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
nausea vomiting emesis PONV post operative nausea and vomiting |
Signs and Symptoms Postoperative Nausea and Vomiting Vomiting Postoperative Complications |
Signs and Symptoms, Digestive Nausea Ondansetron Serotonin |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Antipsychotic Agents Pharmacologic Actions |
Serotonin Antagonists Pathologic Processes Serotonin Agents Autonomic Agents Therapeutic Uses Antipruritics Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Dermatologic Agents |