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

• Sponsor: Drexel University College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00659737
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 115
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.

Condition or Disease	Intervention/Treatment	Phase
Nausea; Vomiting	Drug: Aprepitant; Drug: Scopolamine	N/A

Detailed Description

Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use of resources costs the health care industry hundreds of millions of dollars annually. Patient satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and the treatment is multimodal.

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Aprepitant Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo	Drug: Aprepitant; 40mg tablet; Other Names: Emend (Aprepitant) + Placebo
Active Comparator: Scopolamine Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.	Drug: Scopolamine; 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days; Other Names: Scopolamine + Emend (Aprepitant)

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Postoperative Nausea and Vomiting [0-24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient must be between 18 and 65 years of age.

• Patient's ASA (American Society of Anesthesiologist) class must be between 1 and 3.

• If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study.

• Patient must have 1 FACTOR to qualify

• Female Sex

• History of PONV

• Motion Sickness

• Non-Smoker

• Intended Use of Post Operative Opioids

Exclusion Criteria:

• Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition.

• The surgical procedure is less than 1 hour.

• The patient is pregnant or breast feeding.

• The patient has taken antiemetic medication in previous 24 hours.

• Patients with narrow-angle glaucoma.

• Allergy to belladonna alkaloids.

• Hypersensitivity to barbiturates.

• Patient taking any of the following medications:

• Orap

• Seldane

• Hismanal

• Propulsid

• Phenytoin

• Phenothiazines

• Tricyclic Antidepressants

• Meperidine

• Tolbutamide

• Aluminum and Magnesium Trisilicate-containing Antacids

• Anti-Cholinergics

• Coumadin

• Male patients with prostate hypertrophy.

• Patients with severe hepatic disease.

• Patients on Chemotherapy and taking Aprepitant.

• Patients with fever.

• Patients with sepsis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hahnemann University Hospital	Philadelphia	Pennsylvania	United States	19102

Sponsors and Collaborators

• Drexel University College of Medicine
• Merck Sharp & Dohme LLC

Investigators

• Study Director: Jay Horrow, MD, Drexel University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Drexel University College of Medicine
• ClinicalTrials.gov Identifier: NCT00659737
• Other Study ID Numbers: 20071433
• First Posted: Apr 16, 2008
• Last Update Posted: May 15, 2014
• Last Verified: Sep 1, 2013

• Keywords provided by Drexel University College of Medicine: Post-operative Nausea and Vomiting (PONV)
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Scopolamine; Aprepitant; Fosaprepitant; Butylscopolammonium Bromide

Study Results

Participant Flow

Arm/Group Title	Aprepitant and Placebo Transdermal Patch	Aprepitant and Scopolamine Transdermal Patch
Arm/Group Description	Oral Aprepitant pill 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.	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.
Period Title: Overall Study
STARTED	57	58
COMPLETED	57	58
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Aprepitant and Placebo Transdermal Patch	Aprepitant and Scopolamine Transdermal Patch	Total
Arm/Group Description	Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.	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 of all reporting groups
Overall Participants	57	58	115
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	47.2 (11.27)	46.3 (11.06)	46.8 (11.17)
Sex: Female, Male (Count of Participants)
Female	52 91.2%	51 87.9%	103 89.6%
Male	5 8.8%	7 12.1%	12 10.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Postoperative Nausea and Vomiting
Time Frame	0-24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant and Placebo Transdermal Patch	Aprepitant and Scopolamine Transdermal Patch
Arm/Group Description	Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.	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
Measure Participants	57	58
Number [participants]	28 49.1%	34 58.6%

Adverse Events

Time Frame	0-24 hours
Arm/Group Title	Aprepiatnt		Scopolamine
Arm/Group Description	Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo: 40mg tablet		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
All Cause Mortality
	Aprepiatnt		Scopolamine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Aprepiatnt		Scopolamine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/58 (0%)
Other (Not Including Serious) Adverse Events
	Aprepiatnt		Scopolamine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/57 (50.9%)		34/58 (58.6%)
Gastrointestinal disorders
Dry mouth	29/57 (50.9%)	29	34/58 (58.6%)	34

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.