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

Merck Sharp & Dohme LLC216 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

216

Conditions

Post-Operative Nausea and Vomiting

Interventions

Comparator: MK0517DRUG

a single administration of 40 mg MK0517 by IV immediately prior to surgery

Comparator: ondansetronDRUG

a single administration of 4 mg ondansetron by IV immediately prior to surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Baseline and 24 hours

Secondary Outcomes

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

Time frame: 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

Time frame: Baseline and 24 hours

Data from ClinicalTrials.gov

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