Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250744
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2005-11-04
Brief Title:
Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting
Sponsor:
New Mexico Cancer Care Alliance
Organization:
New Mexico Cancer Care Alliance
Study Overview
Official Title:
Comparison of Aprepitant vs Gabapentin in the Prevention of Delayed Nausea and Vomiting
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To compare the effectiveness of gabapentin titrated to300mg TID days -2 to 5 with aprepitant 125mg on day 1 and 80mg on days 2 and 3 in the control of delayed nausea and vomiting associated with level 3 4 or 5 emetogenic chemotherapy in patients who experienced delayed nausea andor vomiting during their first cycle of chemotherapy
2 To evaluate and compare the safety profile associated with each anti-emetic regimen
3 To assess subject satisfaction with anti-emetic therapy
2 To evaluate and compare the safety profile associated with each anti-emetic regimen
3 To assess subject satisfaction with anti-emetic therapy
Detailed Description:
The purpose of study is to compare the effectiveness of aprepitant and gabapentin in treating delayed days later nausea andor vomiting for patients receiving chemotherapy treatment for cancer Patients on the study will receive aprepitant or gabapentin in addition to the standard medications used to prevent nausea and vomiting Aprepitant is approved by the FDA for nausea and vomiting Gabapentin is approved by the FDA for the treatment of seizures but it may be effective in controlling nausea and vomiting due to chemotherapy Subjects receiving aprepitant will be receiving a proven treatment for delayed nausea and vomiting while subjects receiving gabapentin will be receiving a drug that has only shown limited effectiveness
Patients are eligible for participation in this study because they are going to receive chemotherapy that may cause nausea or vomiting If patients have delayed nausea or vomiting after the first cycle of treatment they will be offered a chance to receive additional treatments with their second cycle of chemotherapy The University of New Mexico Health Sciences Center is sponsoring the study
The first 40 patients enrolled in the study will participate in the pilot phase of the study A pilot study is a smaller version of a full study to determine how effective the treatments are All 40 patients in the pilot phase of the study will come from UNM If the pilot phase is found to be successful then the study will continue and approximately 200 patients will eventually be enrolled The full study will be conducted at the University of New Mexico Cancer Research and Treatment Center UNM CRTC the New Mexico VA Healthcare System and at members of the New Mexico Cancer Care Alliance
Patients are eligible for participation in this study because they are going to receive chemotherapy that may cause nausea or vomiting If patients have delayed nausea or vomiting after the first cycle of treatment they will be offered a chance to receive additional treatments with their second cycle of chemotherapy The University of New Mexico Health Sciences Center is sponsoring the study
The first 40 patients enrolled in the study will participate in the pilot phase of the study A pilot study is a smaller version of a full study to determine how effective the treatments are All 40 patients in the pilot phase of the study will come from UNM If the pilot phase is found to be successful then the study will continue and approximately 200 patients will eventually be enrolled The full study will be conducted at the University of New Mexico Cancer Research and Treatment Center UNM CRTC the New Mexico VA Healthcare System and at members of the New Mexico Cancer Care Alliance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None