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Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy

NCT00880191 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2016-07-06

Study results available
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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.

Conditions

  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

dexamethasone

Given orally

DRUG

gabapentin

Given orally

OTHER

placebo

Given orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Debra Barton, RN, PhD, AOCN, FAAN · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-03-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00880191 on ClinicalTrials.gov