CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 430 enrolled
Drug / intervention
dexamethasone +2 moredrug
Likely dose
Not stated in 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/NCT00880191
NCT00880191Phase 3Completed
CompareCT.gov

Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patients Receiving Highly Emetogenic Chemotherapy

Alliance for Clinical Trials in Oncology·interventional·Posted Apr 13, 2009·Updated Jul 6, 2016

In Brief

A Phase 3 clinical trial evaluating dexamethasone, gabapentin, and 1 other intervention for Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific. Completed, enrolled 430 participants across 247 sites.

Detailed Summary

RATIONALE: Gabapentin may prevent or reduce delayed nausea and vomiting caused by chemotherapy. It is not yet known whether gabapentin is more effective than a placebo in preventing nausea and vomiting. PURPOSE: This randomized phase III trial is studying the side effects of gabapentin and to see how well it works compared with a placebo in preventing nausea and vomiting in patients receiving chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2009
Enrollment StartApr 1, 2009
Primary CompletionMar 1, 2011
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.2 years ago

Interventions

dexamethasonedrug

Given orally

gabapentindrug

Given orally

placeboother

Given orally