Back to resultsA Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)
Primary Purpose
Post-Operative Nausea and Vomiting
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: MK0517
Comparator: ondansetron
Sponsored by
About this trial
This is an interventional prevention trial for Post-Operative Nausea and Vomiting
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
40 mg MK0517 IV
4 mg ondansetron IV
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT00231777
First Posted
September 30, 2005
Last Updated
August 18, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00231777
Brief Title
A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
40 mg MK0517 IV
Arm Title
2
Arm Type
Active Comparator
Arm Description
4 mg ondansetron IV
Intervention Type
Drug
Intervention Name(s)
Comparator: MK0517
Intervention Description
a single administration of 40 mg MK0517 by IV immediately prior to surgery
Intervention Type
Drug
Intervention Name(s)
Comparator: ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
a single administration of 4 mg ondansetron by IV immediately prior to surgery
Primary Outcome Measure Information:
Title
Number of Patients With Clinical Adverse Experiences (CAEs)
Description
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
Title
Number of Patients With Laboratory Adverse Experiences (LAEs)
Description
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 Outcome Measure Information:
Title
Number of Patients With Drug-related CAEs
Description
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
Title
Number of Patients With Serious CAEs
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)
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