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

This study has been completed.
Sponsor:
Collaborator:
Siriraj Hospital
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01093690
First received: March 24, 2010
Last updated: November 4, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Cancer
 Drug: metoclopramide
Drug: placebo

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Number of Patients Who Had Complete Response [ Time Frame: 5 days after receiving chemotherapy ] [ Designated as safety issue: No ]
    number of patients who experience no emesis and need no rescue treatment in 5-day period


Secondary Outcome Measures:
  • Toxicities and Severity of Nausea and Vomiting [ Time Frame: 5 days after receiving chemotherapy ] [ Designated as safety issue: Yes ]

Enrollment: 162
Study Start Date: April 2009
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: metoclopramide
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
 Drug: metoclopramide
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg oral four times a day on day 2-5
Other Name: plasil
Placebo Comparator: placebo
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5
 Drug: placebo
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093690

Locations
Thailand
Division of medical oncology, department of medicine Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Siriraj Hospital
Investigators
Principal Investigator: Suthinee Ithimakin, MD Faculty of medicine Siriraj Hospital
  More Information

No publications provided

Responsible Party: Suthinee Ithimakin, Division of medical oncology, department of medicine, Faculty of Medicine Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01093690     History of Changes
Other Study ID Numbers: Si094/2009
Study First Received: March 24, 2010
Results First Received: October 10, 2010
Last Updated: November 4, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
chemotherapy induced nausea and vomiting, metoclopramide

Additional relevant MeSH terms:
Antiemetics
Dexamethasone
Metoclopramide
Ondansetron
Cisplatin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
 Antineoplastic Agents
Radiation-Sensitizing Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013