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Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

NCT ID: NCT01536691

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):

Prospective multicenter, randomized, single blinded, phase III study.

Detailed Description

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To assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):

Conditions

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Cancer Malignancy

Keywords

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ramosetron ondansetron aprepitant chemotherapy induced nausea & vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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ramosetron, aprepitant, dexamethasone

ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

Group Type EXPERIMENTAL

ramosetron

Intervention Type DRUG

ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

ondansetron, aprepitant, dexamethasone

ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

Group Type ACTIVE_COMPARATOR

ondansetron

Intervention Type DRUG

ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

Interventions

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ramosetron

ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

Intervention Type DRUG

ondansetron

ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

Intervention Type DRUG

Other Intervention Names

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Nasea - ramosetron Emend - aprepitant zofran - ondansetron Emend - aprepitant

Eligibility Criteria

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Inclusion Criteria

1. Patients diagnosed as malignancy who will be treated with highly emetogenic chemotherapeutic agents (NCCN guideline v1.0 2011 anti-emesis), over 20 years and both sex
2. ECOG performance status 0-2
3. Available oral administration of study drugs
4. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria

1. Severe Hypertension, severe Heart disease, kidney disease (serum creatinine \> 3 mg/dl), liver disease (AST, ALT \> 3 times of upper normal range, ALP \> 2 times of upper normal range)
2. Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting
3. Patients who have nausea and vomiting within 1 week before chemotherapy
4. Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases
5. Patients with brain tumor, brain metastasis or seizure
6. Patients receiving chemotherapy within 12 months before enrollment
7. Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy
8. Patients who have known allergy or severe side effect on study drugs
9. Pregnant or lactating women, or women who wish to become pregnant
10. Others whom the investigator judges inappropriate as subjects for this study
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korean Cancer Study Group

OTHER

Sponsor Role collaborator

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role collaborator

Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sangwon Shin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

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Hyo Jung Kim

Anyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyo Jung Kim, M.D. Ph.D.

Role: CONTACT

Phone: 82313803704

Email: [email protected]

Jinjoo Hong, R.N.

Role: CONTACT

Phone: 82232763517

Email: [email protected]

Facility Contacts

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Hyo Jung Kim, M.D., Ph.D.

Role: primary

Other Identifiers

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ROAD

Identifier Type: -

Identifier Source: org_study_id