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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Post-Operative Nausea and Vomiting

Treatments: Drug: Comparator: ondansetron; Drug: Comparator: MK0517

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231777

2005_074

0517-015

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups

1

Experimental group

Description:

40 mg MK0517 IV

Treatment:

Drug: Comparator: MK0517

2

Active Comparator group

Description:

4 mg ondansetron IV

Treatment:

Drug: Comparator: ondansetron