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

M

Mahidol University

Status

Completed

Conditions

Cancer

Treatments

Drug: placebo
Drug: metoclopramide

Study type

Interventional

Funder types

Other

Identifiers

NCT01093690
Si094/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

162 participants in 2 patient groups, including a placebo group

metoclopramide
Experimental group
Description:
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
Treatment:
Drug: metoclopramide
placebo
Placebo Comparator group
Description:
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
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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