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A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)

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: NCT00231777
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : June 8, 2010
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
A new intravenous medication is being tested for the prevention of the nausea and vomiting that occurs after surgery. This new medication is being compared to another intravenous medication that is already available to patients for this indication.

Condition or disease Intervention/treatment Phase
Post-Operative Nausea and Vomiting Drug: Comparator: MK0517 Drug: Comparator: ondansetron Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety and Tolerability of IV MK0517 for the Prevention of Postoperative Nausea and Vomiting (PONV)
Study Start Date : July 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
40 mg MK0517 IV
 Drug: Comparator: MK0517
a single administration of 40 mg MK0517 by IV immediately prior to surgery
Active Comparator: 2
4 mg ondansetron IV
 Drug: Comparator: ondansetron
a single administration of 4 mg ondansetron by IV immediately prior to surgery
Other Name: Zofran


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Clinical Adverse Experiences (CAEs) [ Time Frame: Baseline and 24 hours ]
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

  2. Number of Patients With Laboratory Adverse Experiences (LAEs) [ Time Frame: Baseline and 24 hours ]
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.


Secondary Outcome Measures :
  1. Number of Patients With Drug-related CAEs [ Time Frame: Baseline and 24 hours ]
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

  2. Number of Patients With Serious CAEs [ Time Frame: Baseline and 24 hours ]
    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Open abdominal surgery requiring 24 hour hospital stay
  • General anesthesia
  • Post-operative opioids
  • ASA status of I-III

Exclusion Criteria:

  • Patient exhibits evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or cardiovascular condition or congestive heart failure (CHF)
  • Morbid obesity
  • Patient is mentally incapacitated or has a significant emotional or psychiatric disorder
Contacts and Locations
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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): NCT00231777


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00231777    
Other Study ID Numbers: 0517-015
2005_074
First Posted: October 4, 2005    Key Record Dates
Results First Posted: June 8, 2010
Last Update Posted: August 19, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Ondansetron
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Neurokinin-1 Receptor Antagonists