drugset / Trial / NCT01052844

Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

NCT01052844 ↗

Phase 3 Completed 80 enrolled Faculdade de Medicina do ABC
RandomizedParallel-groupTriple-blindTreatment

Summary

Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy induced emesis. The purpose of this study is to determine whether the addition of gabapentin to dexamethasone plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.

Timeline

Start
2009-01
Primary completion
2010-07
Completion
2010-07

Outcome

Mixed primary results

paper The proportion of patients achieving complete response improved from 40% to 62.5%, (p = 0.04) when comparing the control group and the gabapentin group, respectively. PMID 21465325 ↗

registry analysis (superiority or other test); Control Group vs Gabapentin; p = 0.06; Chi-squared NCT01052844 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gabapentin Unknown 300 mg Oral
Comparator Dexamethasone Small molecule 4 mg Intravenous
Comparator Ondansetron Other / unclassified 8 mg —
Comparator Ranitide Unknown 50 mg —

Indications