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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00231777
First received: September 30, 2005
Last updated: October 22, 2010
Last verified: October 2010

September 30, 2005
October 22, 2010
July 2005
November 2005   (final data collection date for primary outcome measure)
  • Number of Patients With Clinical Adverse Experiences (CAEs) [ Time Frame: Baseline and 24 hours ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline and 24 hours ] [ Designated as safety issue: Yes ]
    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.
To establish safety of Study Drug.
Complete list of historical versions of study NCT00231777 on ClinicalTrials.gov Archive Site
  • Number of Patients With Drug-related CAEs [ Time Frame: Baseline and 24 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 24 hours ] [ Designated as safety issue: Yes ]
    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
Not Provided
Not Provided
Not Provided
 
A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)(COMPLETED)
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Post-Operative Nausea and Vomiting
  • Drug: Comparator: MK0517
    a single administration of 40 mg MK0517 by IV immediately prior to surgery
  • Drug: Comparator: ondansetron
    a single administration of 4 mg ondansetron by IV immediately prior to surgery
    Other Name: Zofran
  • Experimental: 1
    40 mg MK0517 IV
    Intervention: Drug: Comparator: MK0517
  • Active Comparator: 2
    4 mg ondansetron IV
    Intervention: Drug: Comparator: ondansetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
216
February 2006
November 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00231777
MK-0517-015, 2005_074
No
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP