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

Post-Operative Nausea and Vomiting Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231777
• Other study ID #: 0517-015
• Secondary ID: 2005_074
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2005
• Last updated: August 18, 2015
• Start date: July 2005
• Est. completion date: November 2005

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Post-Operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Comparator: MK0517
a single administration of 40 mg MK0517 by IV immediately prior to surgery
• Comparator: ondansetron
a single administration of 4 mg ondansetron by IV immediately prior to surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes