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Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis

NCT00869310 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2014-01-06

No results posted yet for this study

Summary

The aim of the study is to compare efficacy and tolerability of aprepitant plus dexamethasone versus metoclopramide plus dexamethasone in the prevention of cisplatin-induced delayed emesis in patients that received aprepitant, palonosetron and dexamethasone before chemotherapy administration for the prevention of acute emesis.

Conditions

  • Emesis

Interventions

DRUG

aprepitant + dexamethasone

Dexamethasone 8 mg orally: 24 hours after chemotherapy (day 2) and then at 8 am on days 3-4 plus Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3.

DRUG

metoclopramide + dexamethasone

dexamethasone 8 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on days 3-4 plus Metoclopramide 20 mg orally 4 times a day: 24 hours after chemotherapy and then at 4 pm, 7 pm, 10 pm on day 2 then at 7 am, 12 am, 5 pm, 10 pm on days 3-4.

Sponsors & Collaborators

  • S. Maria Hospital, Terni

    lead OTHER

Principal Investigators

  • Fausto Roila, MD · Oncology Division, S. Maria Hospital, Terni, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Italy

Study Locations

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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 NCT00869310 on ClinicalTrials.gov