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

NCT00231777 | Completed Phase 3 Results

• 2 other identifiers: 0517-0152005_074
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post-Operative Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Clinical Adverse Experiences (CAEs)

  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)

  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 Outcomes (2)

• Number of Patients With Drug-related CAEs

  Baseline and 24 hours

• Number of Patients With Serious CAEs

  Baseline and 24 hours

Study Arms (2)

1

EXPERIMENTAL

40 mg MK0517 IV

Drug: Comparator: MK0517

2

ACTIVE COMPARATOR

4 mg ondansetron IV

Drug: Comparator: ondansetron

Interventions

Comparator: MK0517 DRUG

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

1

Comparator: ondansetron DRUG

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

Also known as: Zofran

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open abdominal surgery requiring 24 hour hospital stay
• General anesthesia
• Post-operative opioids
• ASA status of I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

The formulation of MK0517 used in this study was a non polysorbate (PS80) formulation which was not further developed and is not available for use.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: July 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: August 19, 2015
• Results First Posted: June 8, 2010

Record last verified: 2015-08