A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)
Completed
Schering-Plough
Phase 2
2006-09-01
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.
Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)
Completed
Merck Sharp & Dohme Corp.
Phase 2
2007-01-01
This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH
619734 in subjects with chronic cough from an unknown cause. Subjects will be randomized to
receive SCH 619734 or placebo for 7 days with 7 days' follow-up. After a 6 week washout
period, subjects will be crossed over to the other treatment. The primary objective is to
evaluate the effectiveness of SCH 619734 in reducing cough reflex sensitivity as determined
by a challenge with capsaicin, an agent that induces cough.
A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)
Completed
Merck Sharp & Dohme Corp.
Phase 2
2007-10-01
This is a multicenter, randomized, controlled study in women who are having elective open
abdominal surgery with general anesthesia and who are expected to need patient-controlled
analgesia (PCA) after surgery. The primary objective is to assess the effect of rolapitant in
the prevention of postoperative nausea and vomiting as measured by the prevention of vomiting
in the first 24 hours after surgery. Participation in the study may last up to 3 months. The
total duration of the study will be approximately 36 weeks.
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