Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting
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|ClinicalTrials.gov Identifier: NCT00250744|
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : September 27, 2011
- 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 and/or vomiting during their first cycle of chemotherapy.
- To evaluate and compare the safety profile associated with each anti-emetic regimen.
- To assess subject satisfaction with anti-emetic therapy.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Aprepitant vs. Gabapentin||Phase 2|
The purpose of study is to compare the effectiveness of aprepitant and gabapentin in treating "delayed" (days later) nausea and/or 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Aprepitant vs. Gabapentin in the Prevention of Delayed Nausea and Vomiting|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
|Experimental: Arm A||
Drug: Aprepitant vs. Gabapentin
Gabapentin 300mg PO QHS day -2; 300mg PO BID day -1; 300mg PO TID days 0 through +5.
|Active Comparator: Arm B||
Drug: Aprepitant vs. Gabapentin
Aprepitant 125mg PO 60 minutes prior to chemotherapy on day 0; 80 mg PO QAM on days +1 and +2.
- To compare the effectiveness of gabapentin with aprepitant in the control of delayed nausea & vomiting associated with level 3, 4 or 5 emetogenic chemotherapy in pts who experienced delayed nausea and/or vomiting during their first cycle of chemotherapy. [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250744
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Stanley Cheshire||University of New Mexico|