Trial Outcomes & Findings for Aprepitant for Post-operative Nausea (NCT NCT01020903)

NCT ID: NCT01020903

Last Updated: 2023-11-22

Results Overview

Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2023-11-22

Participant Flow

Participant milestones

Measure	Aprepitant Aprepitant: 40 mg po pre-op	Placebo Placebo: Orally, pre-op
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aprepitant for Post-operative Nausea

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Records for this study are no longer available as they were destroyed in Hurricane Sandy in 10/2012- we do not have any information to use to update the records. The PI for this study is no longer with the institution and no contact information is available. Since we cannot verify the # of participants analyzed, the numbers were changed to "0".

Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.

Outcome measures

Outcome data not reported

Adverse Events

Aprepitant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Silverberg/Principal Investigator

Staten Island University Hospital

Phone: 718-226-6629

Email: msilverberg@siuh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place