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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR ROLAPITANT HYDROCHLORIDE

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Clinical Trials for Rolapitant Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00394966 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 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.
NCT00506545 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 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.
NCT00539721 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 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.
NCT01499849 Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy Completed Tesaro, Inc. Phase 3 This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Rolapitant Hydrochloride

Condition Name

Condition Name for Rolapitant Hydrochloride
Intervention Trials
Chemotherapy-induced Nausea and Vomiting 7
Nausea 1
Cough 1
Chemo-radiation Induced Nausea and Vomiting 1
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Condition MeSH

Condition MeSH for Rolapitant Hydrochloride
Intervention Trials
Vomiting 11
Nausea 8
Glioma 1
Sarcoma 1
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Clinical Trial Locations for Rolapitant Hydrochloride

Trials by Country

Trials by Country for Rolapitant Hydrochloride
Location Trials
United States 8
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Trials by US State

Trials by US State for Rolapitant Hydrochloride
Location Trials
Maryland 3
Massachusetts 3
North Carolina 1
Texas 1
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Clinical Trial Progress for Rolapitant Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Rolapitant Hydrochloride
Clinical Trial Phase Trials
Phase 3 3
Phase 2 6
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Rolapitant Hydrochloride
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 2
Recruiting 1
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Clinical Trial Sponsors for Rolapitant Hydrochloride

Sponsor Name

Sponsor Name for Rolapitant Hydrochloride
Sponsor Trials
Tesaro, Inc. 8
Merck Sharp & Dohme Corp. 2
Schering-Plough 1
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Sponsor Type

Sponsor Type for Rolapitant Hydrochloride
Sponsor Trials
Industry 11
Other 4
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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Fish and Richardson
Moodys
Citi
Dow
Chinese Patent Office
McKesson
Cantor Fitzgerald

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