CompletedPhase 3

A Study of the Drug Casopitant for the Prevention of Nausea Caused By Cisplatin-Based Highly Emetogenic Chemotherapy

Argentina, Belgium810 participantsStarted 2006-11-06

Plain-language summary

This is a Phase III trial designed to demonstrate that casopitant when added to dexamethasone and ondansetron is more effective in the prevention of vomiting then dexamethasone and ondansetron alone, in patients who receive a cisplatin-based highly emetogenic chemotherapy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses)
✓. child-bearing potential: must have a negative serum pregnancy test result or negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product of cycle 1 day 1, and agrees to one of the following:

What they're measuring

Number of participants who achieved complete response

Timeframe: Up to 120 hours of cycle 1 of HEC

Trial details

NCT IDNCT00431236

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-10-09

View on ClinicalTrials.gov More Nausea and Vomiting, Chemotherapy-Induced trials