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Completed

NCT Number: NCT00231777

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

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.

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Key information

Conditions

Post-operative Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: MK0517

Drug

a single administration of 40 mg MK0517 by IV immediately prior to surgery

Comparator: ondansetron

Drug

a single administration of 4 mg ondansetron by IV immediately prior to surgery

Other names: Zofran

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Oct 4, 2005
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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