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

Phase 3

Completed

• Conditions: Post-Operative Nausea and Vomiting

• Registration Number: NCT00231777
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Results First Submitted: 2010-05-10
• Results First Submitted QC: 2010-05-10
• Results First Posted: 2010-06-08
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Patients With Clinical Adverse Experiences (CAEs)	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
Number of Patients With Laboratory Adverse Experiences (LAEs)	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

Name	Time	Method
Number of Patients With Drug-related CAEs	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
Number of Patients With Serious CAEs	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