NCT00394966 - A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED) | Biotech Hunter

Enrollment

450

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions

NauseaVomiting

Interventions

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)