N/A
N=162
Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01093690 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Number of Patients Who Had Complete Response — 50; 42 participants — p=0.41
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- metoclopramide (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mahidol University
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Had Complete Response |
50; 42 | 0.41 |
| SECONDARY Toxicities and Severity of Nausea and Vomiting |
— | — |
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.
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
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.