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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Post-Operative Nausea and Vomiting

Intervention / Treatment
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* Drug: Comparator: MK0517
* Drug: Comparator: ondansetron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>40 mg MK0517 IV | Drug: Comparator: MK0517<br>* a single administration of 40 mg MK0517 by IV immediately prior to surgery<br>|
| Active Comparator: 2<br>4 mg ondansetron IV | Drug: Comparator: ondansetron<br>* a single administration of 4 mg ondansetron by IV immediately prior to surgery<br>* Other names: Zofran;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Clinical Adverse Experiences (CAEs) | 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 | Baseline and 24 hours | 
| Number of Patients With Laboratory Adverse Experiences (LAEs) | 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. | Baseline and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | Baseline and 24 hours | 
| Number of Patients With Serious CAEs | 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 | Baseline and 24 hours |