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

Open-label Extension to: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00092196
Enrollment
820
Registered
2004-09-24
Start date
2002-12-01
Completion date
2004-12-01
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Nausea, Vomiting

Keywords

Chemotherapy-Induced Nausea and Vomiting

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.

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Safety and tolerability

Secondary

MeasureTime frame
Assessment of adverse experiences using the National Cancer Institute (NCI) criteria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026