DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: metoclopramide (Drug); placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Suthinee Ithimakin, MD, Principal Investigator, Affiliation: Faculty of medicine Siriraj Hospital

Summary

The objective of this study is to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.

Clinical Details

Official title: Randomized, Placebo-controlled Trial of Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis in Patients Receiving High Dose Cisplatin in Routine Medical Practice

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Patients Who Had Complete Response

Secondary outcome: Toxicities and Severity of Nausea and Vomiting

Detailed description: Ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- schedule to receive first cycle of cisplatin > 50 mg/m^2

- pathologically or histologically confirmed solid cancer

- more than 18 years old

- creatinine clearance more than 50 ml/min

- aminotransferase less than 2 times of upper normal limit

Exclusion Criteria:

- pregnant woman

- patients with episode of vomiting within 24 hours prior to chemotherapy session

- gut obstruction

- brain metastasis

- abdominal or pelvic irradiation

- no history of allergy to study drugs

Locations and Contacts

Division of medical oncology, department of medicine Siriraj Hospital, Bangkok 10700, Thailand
Additional Information

Starting date: April 2009
Last updated: November 4, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017