Clinical trial · Interventional
Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin
Randomized, Placebo-controlled Trial of Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis in Patients Receiving High Dose Cisplatin in Routine Medical Practice
NCT01093690CI-TRIAL-00004160completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metoclopramide | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- metoclopramide
- 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
- interventionNames
- Drug: metoclopramide
- type
- PLACEBO_COMPARATOR
- label
- placebo
- 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
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Number of Patients Who Had Complete Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.