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NCT00090207 Clinical Trial

Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)

Nausea Clinical Trial

Official title:
A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00090207
Other study ID # 0869-801
Secondary ID 2004_005
Status Completed
Phase Phase 4
First received August 25, 2004
Last updated April 20, 2017
Start date January 13, 2004
Est. completion date September 30, 2004

Study information
Verified date April 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.

Recruitment information / eligibility
Status Completed
Enrollment 477
Est. completion date September 30, 2004
Est. primary completion date September 30, 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient is greater than 18 years of age.

- Patient is scheduled to receive his/her first

course of cisplatin chemotherapy for a solid tumor.

- Patient has a prognosis (life expectancy) greater than or equal to 3 months.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0869, aprepitant / Duration of Treatment: 3 days

• Comparator: ondansetron / Duration of Treatment: 4 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Schmoll HJ, Aapro MS, Poli-Bigelli S, Kim HK, Park K, Jordan K, von Pawel J, Giezek H, Ahmed T, Chan CY. Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Ann Oncol. 2006 Jun;17(6):1000-6. Epub 2006 Mar 8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Patient vomiting
Secondary Number of rescue therapies
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