- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00231777
A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)
August 18, 2015 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
216
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
40 mg MK0517 IV
|
a single administration of 40 mg MK0517 by IV immediately prior to surgery
|
Active Comparator: 2
4 mg ondansetron IV
|
a single administration of 4 mg ondansetron by IV immediately prior to surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Clinical Adverse Experiences (CAEs)
Time Frame: 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
|
Baseline and 24 hours
|
Number of Patients With Laboratory Adverse Experiences (LAEs)
Time Frame: 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.
|
Baseline and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Drug-related CAEs
Time Frame: 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
|
Baseline and 24 hours
|
Number of Patients With Serious CAEs
Time Frame: 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
|
Baseline and 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
September 30, 2005
First Submitted That Met QC Criteria
September 30, 2005
First Posted (Estimate)
October 4, 2005
Study Record Updates
Last Update Posted (Estimate)
August 19, 2015
Last Update Submitted That Met QC Criteria
August 18, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Neurokinin-1 Receptor Antagonists
- Ondansetron
- Aprepitant
Other Study ID Numbers
- 0517-015
- 2005_074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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