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

NCT ID: NCT01093690

Last Updated: 2010-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Keywords

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chemotherapy induced nausea and vomiting, metoclopramide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

metoclopramide

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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plasil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Division of medical oncology, department of medicine, Faculty of Medicine Siriraj Hospital

Principal Investigators

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Suthinee Ithimakin, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Division of medical oncology, department of medicine Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Si094/2009

Identifier Type: -

Identifier Source: org_study_id