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A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY, INDUCED UNDER INTERNAL BLIND CONDITIONS, TO DETERMINE THE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF THE APREPITANT REGIME COMPARED TO AN ONDASETRON REGIME FOR THE PREVENTION OF NAUSEA AND VOMITES INDUCED BY CHEMOTHERAPY, ASSOCIATED WITH HIGH DOSE OF CISPLATINO IN CYCLE 1.

A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY, INDUCED UNDER INTERNAL BLIND CONDITIONS, TO DETERMINE THE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF THE APREPITANT REGIME COMPARED TO AN ONDASETRON REGIME FOR THE PREVENTION OF NAUSEA AND VOMITES INDUCED BY CHEMOTHERAPY, ASSOCIATED WITH HIGH DOSE OF CISPLATINO IN CYCLE 1.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-057-03
Enrollment
32
Registered
2003-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Prepitant Type of group
Prepitant capsule of 80 mg + ondansetron 1 capsule of 8 mg of placebo every 12 hours + dexamethasone 4 mg 2 tablets in the morning Group name:Ondasetron Type of group
placebo of prepitant capsule of 80 mg + ondasetron 1 capsule of 8 mg every 12 hours + dexamethasone 4 mg 2 tablets in the morning

Sponsors

MERCK & CO.INC.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patient is> 18 years of age. The patient is scheduled to receive his first cycle of cisplatin chemotherapy for a malignant solid tumor documented at a dose of> 70 mg / m administered for 60. The patient has a predicted life expectancy of> 3 months.

Exclusion criteria

Exclusion criteria: The patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, excludes him from participating in the study. The patient receives stem cell rescue therapy along with the cisplatin chemotherapy cycle. The patient has received an unapproved (investigational) drug within the last 4 weeks.

Design outcomes

Primary

MeasureTime frame
Outcome name:nausea and vomiting Measure:Aprepitant regimen with the Ondansetron regimen in the proportion of patients with Complete Response in the 120 hours after chemotherapy. Timepoints:120 hours—

Secondary

MeasureTime frame
Outcome name:Nausea and vomiting Measure:To compare the Aprepitant regimen with the Ondansetron regimen in the proportion of patients with Complete Response - 25 to 120 hours. Timepoints:25 - 120 hours—

Countries

Peru, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)