Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659737
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : April 29, 2014
Last Update Posted : May 15, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Nausea Vomiting Drug: Aprepitant Drug: Scopolamine Not Applicable

Detailed Description:
Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use of resources costs the health care industry hundreds of millions of dollars annually. Patient satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and the treatment is multimodal.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Study Start Date : April 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Aprepitant

Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.

Emend (Aprepitant) + Placebo

 Drug: Aprepitant
40mg tablet
Other Name: Emend (Aprepitant) + Placebo
Active Comparator: Scopolamine
Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.
 Drug: Scopolamine
1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days
Other Name: Scopolamine + Emend (Aprepitant)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants With Postoperative Nausea and Vomiting [ Time Frame: 0-24 hours ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be between 18 and 65 years of age.
  • Patient's ASA (American Society of Anesthesiologist) class must be between 1 and 3.
  • If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study.

  • Patient must have 1 FACTOR to qualify

    • Female Sex
    • History of PONV
    • Motion Sickness
    • Non-Smoker
    • Intended Use of Post Operative Opioids

Exclusion Criteria:

  • Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition.
  • The surgical procedure is less than 1 hour.
  • The patient is pregnant or breast feeding.
  • The patient has taken antiemetic medication in previous 24 hours.
  • Patients with narrow-angle glaucoma.
  • Allergy to belladonna alkaloids.
  • Hypersensitivity to barbiturates.

  • Patient taking any of the following medications:

    • Orap
    • Seldane
    • Hismanal
    • Propulsid
    • Phenytoin
    • Phenothiazines
    • Tricyclic Antidepressants
    • Meperidine
    • Tolbutamide
    • Aluminum and Magnesium Trisilicate-containing Antacids
    • Anti-Cholinergics
    • Coumadin
  • Male patients with prostate hypertrophy.
  • Patients with severe hepatic disease.
  • Patients on Chemotherapy and taking Aprepitant.
  • Patients with fever.
  • Patients with sepsis.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659737


Locations
Layout table for location information
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University College of Medicine
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Jay Horrow, MD Drexel University College of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00659737    
Other Study ID Numbers: 20071433
First Posted: April 16, 2008    Key Record Dates
Results First Posted: April 29, 2014
Last Update Posted: May 15, 2014
Last Verified: September 2013
Keywords provided by Drexel University ( Drexel University College of Medicine ):
Post-operative Nausea and Vomiting (PONV)
Additional relevant MeSH terms:
Layout table for MeSH terms
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Scopolamine
Aprepitant
Fosaprepitant
Butylscopolammonium Bromide
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Muscarinic Antagonists
Parasympatholytics