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Rolapitant Dose 1

Phase 2

Postoperative Nausea and Vomiting | Small molecule | Other |Merck & Company, Inc.|Last Updated: Nov 1, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment619

FDA Designations

No designations recorded

Clinical trial landscape

Rolapitant Dose 1 · 1 trial · 1 indication

Phase 2 1
NCT00539721A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)Postoperative Nausea and Vomiting
COMPLETED619 Analytics
PHASE2COMPLETED
A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)
Postoperative Nausea and VomitingUnlock trial analytics

Study Endpoints

Primary Endpoints

No emetic episodes regardless of rescue medication use.
First 24 hours after surgery.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Rolapitant Dose 1EXPERIMENTAL -
Rolapitant Dose 2EXPERIMENTAL -
Rolapitant Dose 3EXPERIMENTAL -
Rolapitant Dose 4EXPERIMENTAL -
OndansetronACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Rolapitant Dose 1DRUGRolapitant 5 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
Rolapitant Dose 2DRUGRolapitant 20 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
Rolapitant Dose 3DRUGRolapitant 70 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
Rolapitant Dose 4DRUG200 mg (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
OndansetronDRUGOndansetron 4 mg x 1 intravenous and rolapitant placebo (4 capsules) x 1 oral on Day 1
PlaceboDRUGRolapitant placebo (4 capsules) x 1 oral and ondansetron placebo x 1 intravenous on Day 1
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Women aged 18 years or older of any race with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective open abdominal surgery under general anesthesia. * Women whose postoperative hospitalization is expected to last at le...

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Frequently asked questions about Rolapitant Dose 1

What is Rolapitant Dose 1 used for?

Rolapitant Dose 1 is an investigational small molecule being studied for the prevention of postoperative nausea and vomiting (PONV) in female patients aged 18 years and older. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Rolapitant Dose 1?

Rolapitant Dose 1 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical development for postoperative nausea and vomiting.

What phase is Rolapitant Dose 1 in?

Rolapitant Dose 1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the prevention of postoperative nausea and vomiting in adult female patients.

What clinical trials is Rolapitant Dose 1 in?

Rolapitant Dose 1 has one completed Phase 2 clinical trial, identified as NCT00539721. This randomized, double-blind, placebo-controlled study enrolled 619 female participants aged 18 years and older to evaluate the drug for the prevention of postoperative nausea and vomiting following surgery.

Is Rolapitant Dose 1 the same as rolapitant?

Rolapitant Dose 1 is a specific dose formulation of the drug rolapitant. The clinical trial NCT00539721 evaluates this particular dose for the prevention of postoperative nausea and vomiting. The drug is being developed by Merck & Company, Inc. under the ticker MRK.