CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01052844
NCT01052844Phase 3Completed
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Clinical Trial of Gabapentin in the Prevention of Nausea Ond Vomiting Induced by Chemotherapy, a Randomized, Double-blind, Placebo Controled Study

Faculdade de Medicina do ABC·interventional·Posted Jan 20, 2010·Updated Mar 7, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo and Gabapentin for Vomiting and Cisplatin Adverse Reaction. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVomiting, Cisplatin Adverse Reaction
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2010
Enrollment StartJan 1, 2009
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.4 years ago

Interventions

Placebodrug

Placebo, given orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)

Gabapentindrug

Gabapentin 300mg, orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)