NCT00394966

A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)

A Phase 2, MultiCenter, Randomized, Placebo-Controlled, Double-Blind, Dose Finding Study to Determine the Safety and Efficacy of SCH 619734 for the Treatment of Chemotherapy Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Schering-Plough · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6. The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734 pharmacokinetic assessments will be collected. The study is to be conducted in conformance with Good Clinical Practice.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	SCH 619734 Dose 1	SCH 619734 10 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
DRUG	SCH 619734 Dose 2	SCH 619734 25 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
DRUG	SCH 619734 Dose 3	SCH 619734 100 mg (2 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
DRUG	SCH 619734 Dose 4	SCH 619734 200 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
DRUG	Placebo	Matching placebo x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-11-02
• Last updated: 2009-10-23