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

NCT ID: NCT00231777

Last Updated: 2015-08-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Operative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

40 mg MK0517 IV

Group Type EXPERIMENTAL

Comparator: MK0517

Intervention Type DRUG

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

2

4 mg ondansetron IV

Group Type ACTIVE_COMPARATOR

Comparator: ondansetron

Intervention Type DRUG

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

Interventions

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Comparator: MK0517

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

Intervention Type DRUG

Comparator: ondansetron

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

Intervention Type DRUG

Other Intervention Names

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Zofran

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2005_074

Identifier Type: -

Identifier Source: secondary_id

0517-015

Identifier Type: -

Identifier Source: org_study_id

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