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N/A Completed N=162 Randomized Triple-blind Treatment

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

Source: ClinicalTrials.gov NCT01093690 ↗
Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcomePrimary: Number of Patients Who Had Complete Response — 50; 42 participants — p=0.41

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients Who Had Complete Response
50; 42 0.41
SECONDARY
Toxicities and Severity of Nausea and Vomiting

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01093690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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