Trial Outcomes & Findings for Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting (NCT NCT00659737)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

115 participants

Primary outcome timeframe

0-24 hours

Results posted on

2014-05-15

Participant milestones
Measure	Aprepitant and Placebo Transdermal Patch Oral Aprepitant pill 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.	Aprepitant and Scopolamine Transdermal Patch Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure.
Overall Study STARTED	57	58
Overall Study COMPLETED	57	58
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Baseline characteristics by cohort
Measure	Aprepitant and Placebo Transdermal Patch n=57 Participants Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.	Aprepitant and Scopolamine Transdermal Patch n=58 Participants Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure	Total n=115 Participants Total of all reporting groups
Age, Continuous	47.2 Years STANDARD_DEVIATION 11.27 • n=5 Participants	46.3 Years STANDARD_DEVIATION 11.06 • n=7 Participants	46.8 Years STANDARD_DEVIATION 11.17 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	51 Participants n=7 Participants	103 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants

Timeframe: 0-24 hours

Outcome measures
Measure	Aprepitant and Placebo Transdermal Patch n=57 Participants Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.	Aprepitant and Scopolamine Transdermal Patch n=58 Participants Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
Number of Participants With Postoperative Nausea and Vomiting	28 participants	34 participants

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Aprepiatnt n=57 participants at risk Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo: 40mg tablet	Scopolamine n=58 participants at risk Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure. Scopolamine + Emend (Aprepitant): 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days
Gastrointestinal disorders Dry mouth	50.9% 29/57 • Number of events 29 • 0-24 hours	58.6% 34/58 • Number of events 34 • 0-24 hours

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