Aprepitant in the prevention of cisplatin-induced delayed emesis: a double-blind randomized study - Aprepitant for cisplatin-induced delayed emesis

• Conditions: patiens with different cancers submitted to single dose of cisplatin chemotherapy; MedDRA version: 9.1Level: SOCClassification code 10017947; MedDRA version: 9.1Level: HLTClassification code 10028817

• Registration Number: EUCTR2008-001339-37-IT
• Lead Sponsor: AZIENDA OSPEDALIERA S. MARIA DI TERNI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-10
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

- patients submitted for the first time to cisplatin chemotherapy administered in single dose
- patients over 18 years old that signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients submitted on days 2-4 after cisplatin to other antineoplastic agents except 5-fluorouracil, VP16, VM26, vincristine, vinblastine, vindesine, vinorelbine, gemcitabine
- patients already submitted to cisplatin
- patients with serious disease or with predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, hypercalemia and brain metastases
- patients with contraindications to dexamethasone administration (i.e. active peptic ulcer, previous blooding from peptic ulcer
- patients receiving concomitant radiotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified