Study of MK0869 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (0869-071)(COMPLETED)

Phase 3

Completed

• Conditions: Vomiting; Nausea; Breast Neoplasms

• Registration Number: NCT00092196
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12-01
• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-23
• Study First Posted: 2004-09-24
• Primary Completion: 2004-12-01
• Study Completion: 2004-12-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

• Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.
• Patient must have completed participation in the main study for this protocol.

Exclusion Criteria

• Patient has a central nervous system malignancy.
• Patient will receive radiation to the abdomen or pelvis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Assessment of adverse experiences using the National Cancer Institute (NCI) criteria