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

NCT01093690 | Completed Results

• 1 other identifier: Si094/2009
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

chemotherapy induced nausea and vomiting, metoclopramide

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Had Complete Response

  number of patients who experience no emesis and need no rescue treatment in 5-day period

  5 days after receiving chemotherapy

Secondary Outcomes (1)

• Toxicities and Severity of Nausea and Vomiting

  5 days after receiving chemotherapy

Study Arms (2)

metoclopramide

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

metoclopramide 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

Also known as: plasil

metoclopramide

placebo 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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (1)

Division of medical oncology, department of medicine Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Neoplasms; Vomiting

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Results Point of Contact

• Title: Suthinee Ithimakin, MD
• Organization: Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

aesi105@yahoo.co.th

6624197000

Study Officials

• Suthinee Ithimakin, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 26, 2010
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 2, 2010
• Results First Posted: December 2, 2010

Record last verified: 2010-11

Locations

TH (1)