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Sponsors and Collaborators: |
Drexel University Merck |
Information provided by: | Drexel University |
ClinicalTrials.gov Identifier: | NCT00659737 |
Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.
Condition | Intervention |
Nausea Vomiting |
Drug: Emend (Aprepitant) + Placebo Drug: Scopolamine + Emend (Aprepitant) |
MedlinePlus related topics: | Nausea and Vomiting |
ChemIDplus related topics: | Aprepitant Scopolamine Butylscopolammonium bromide Scopolamine Hydrobromide |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | A Randomized, Double-Blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting |
Estimated Enrollment: | 120 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.
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Drug: Emend (Aprepitant) + Placebo
40mg tablet
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2: Active Comparator
Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.
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Drug: Scopolamine + Emend (Aprepitant)
1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient must have 1 FACTOR to qualify
Exclusion Criteria:
Patient taking any of the following medications:
Contact: Michael Green, DO | 215-762-1524 | Michael.Green@DrexelMed.edu |
United States, Pennsylvania | |||||
Hahnemann University Hospital | Recruiting | ||||
Philadelphia, Pennsylvania, United States, 19102 | |||||
Contact: Michael Green, DO 215-762-1524 Michael.Green@DrexelMed.edu | |||||
Principal Investigator: Michael Green, DO |
Drexel University |
Merck |
Study Director: | Jay Horrow, MD | Drexel University College of Medicine |
Responsible Party: | Drexel University College of Medicine ( Michael Green, DO ) |
Study ID Numbers: | 20071433 |
First Received: | April 8, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00659737 |
Health Authority: | United States: Institutional Review Board |
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