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| Name | Class |
|---|---|
| Siriraj Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicities and Severity of Nausea and Vomiting | 5 days after receiving chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suthinee Ithimakin, MD | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of medical oncology, department of medicine Siriraj Hospital | Bangkok | Bangkok | 10700 | Thailand |
All recruited patients were participate enrollment.
Recruitment period from April 2009-June 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metoclopramide | 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 |
| FG001 | Placebo | ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metoclopramide | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Had Complete Response | number of patients who experience no emesis and need no rescue treatment in 5-day period | intention to treat | Posted | Number | participants | 5 days after receiving chemotherapy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metoclopramide | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suthinee Ithimakin, MD | Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University | 6624197000 | 4489 | aesi105@yahoo.co.th |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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|
| 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 |
|
ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Toxicities and Severity of Nausea and Vomiting | Not Posted | 5 days after receiving chemotherapy |
| 0 |
| 83 |
| 67 |
| 83 |
| EG001 | Placebo | ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5 | 0 | 79 | 62 | 79 |
| anorexia | General disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| sleepiness | General disorders | Systematic Assessment |
|
| hiccup | General disorders | Systematic Assessment |
|
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| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |