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| Name | Class |
|---|---|
| Staten Island University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant | Procedure | 40 mg po pre-op |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Nausea and Vomiting | 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael B Silverberg, MD | Staten Island University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10365008 | Background | 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. doi: 10.1093/bja/82.2.274. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant | Aprepitant: 40 mg po pre-op |
| FG001 | Placebo | Placebo: Orally, pre-op |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in 10/2012. thus, we do not have any information to use to update the records. PI for this study is no longer with the institution and no contact information is available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant | Aprepitant: 40 mg po pre-op |
| BG001 | Placebo | Placebo: Orally, pre-op |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Nausea and Vomiting | 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. | 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". | Posted | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aprepitant | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Silverberg/Principal Investigator | Staten Island University Hospital | 718-226-6629 | msilverberg@siuh.edu |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Orally, pre-op |
|
|
| BG002 |
| Total |
Total of all reporting groups |
|
| Sex/Gender, Customized | participants |
|
| Aprepitant vs Placebo | participants |
| OG001 | Placebo | Placebo: Orally, pre-op |
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | 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. | 0 | 0 | 0 | 0 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D002241 |
| Carbohydrates |