Aprepitant for Post-operative Nausea

• Sponsor: Northwell Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01020903
• Collaborator: Staten Island University Hospital (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea	Procedure: Aprepitant; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aprepitant	Procedure: Aprepitant; 40 mg po pre-op; Other Names: Emend
Placebo Comparator: Placebo	Drug: Placebo; Orally, pre-op; Other Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. Post-operative Nausea and Vomiting [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Laparoscopic cholecystectomy patients.

• Must be able to swallow a pill.

Exclusion Criteria:

• Liver failure,

• Age less than 18.

• Pregnancy, breast-feeding.

• Pre-op vomiting.

• Allergy to aprepitant.

• Need for post-op gastric drainage.

• Use of drugs that interact with aprepitant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Staten Island University Hospital	Staten Island	New York	United States	10305

Sponsors and Collaborators

• Northwell Health
• Staten Island University Hospital

Investigators

• Principal Investigator: Michael B Silverberg, MD, Staten Island University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Diemunsch P, Schoeffler P, Bryssine B, Cheli-Muller LE, Lees J, McQuade BA, Spraggs CF. Antiemetic activity of the NK1 receptor antagonist GR205171 in the treatment of established postoperative nausea and vomiting after major gynaecological surgery. Br J Anaesth. 1999 Feb;82(2):274-6.

• Responsible Party: Northwell Health
• ClinicalTrials.gov Identifier: NCT01020903
• Other Study ID Numbers: 09-045
• First Posted: Nov 26, 2009
• Last Update Posted: Jun 4, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Nausea; Postoperative Nausea and Vomiting; Aprepitant

Study Results

Participant Flow

Arm/Group Title	Aprepitant	Placebo
Arm/Group Description	Aprepitant: 40 mg po pre-op	Placebo: Orally, pre-op
Period Title: Overall Study
STARTED	100	100
COMPLETED	100	100
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Aprepitant	Placebo	Total
Arm/Group Description	Aprepitant: 40 mg po pre-op	Placebo: Orally, pre-op	Total of all reporting groups
Overall Participants	0	0	0
Age (Count of Participants)
Sex/Gender, Customized (participants) [Number]
Aprepitant vs Placebo (participants) [Number]

Outcome Measures

1. Primary Outcome

Title	Post-operative Nausea and Vomiting
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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".

Arm/Group Title	Aprepitant	Placebo
Arm/Group Description	Aprepitant: 40 mg po pre-op	Placebo: Orally, pre-op
Measure Participants	0	0

Adverse Events

Arm/Group Title	Aprepitant		Placebo
Arm/Group Description	Aprepitant: 40 mg po pre-op Please be advised that the investigator of the study entitled "Aprepitant for Post-operative Nausea" NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) 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.		Placebo: Orally, pre-op Please be advised that the investigator of the study entitled "Aprepitant for Post-operative Nausea" NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) 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.
All Cause Mortality
	Aprepitant		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Aprepitant		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Aprepitant		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.