EUCTR2008-001339-37-IT
Active, not recruiting
Not Applicable
Aprepitant in the prevention of cisplatin-induced delayed emesis: a double-blind randomized study - Aprepitant for cisplatin-induced delayed emesis
AZIENDA OSPEDALIERA S. MARIA DI TERNI0 sites560 target enrollmentAugust 10, 2009
DrugsEMEND*2CPS 80MG
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AZIENDA OSPEDALIERA S. MARIA DI TERNI
- Enrollment
- 560
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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