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Status unknownNCT01536691ROADUpdated Oct 3, 2012

Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

A Phase 3 interventional study of ramosetron and ondansetron in Cancer and Malignancy, sponsored by Hallym University Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-10-03.

Sponsored by Hallym University Medical Center · Phase 3, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
338
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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):

02

Conditions studied

  • Cancer
  • Malignancy

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Keywords

  • ramosetron
  • ondansetron
  • aprepitant
  • chemotherapy induced nausea & vomiting
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 338 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Hallym University Medical Center is the lead sponsor of 52 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
338 participants (estimated)

Study arms

  • Experimental
    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

    Drug: ramosetron

  • Active comparator
    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

    Drug: ondansetron

Interventions

  • Drugramosetron

    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

    Also known as: Nasea - ramosetron, Emend - aprepitant

  • Drugondansetron

    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

    Also known as: zofran - ondansetron, Emend - aprepitant

06

What researchers measure

Primary outcomes

  1. complete response (CR)

    CR means no vomiting \& no rescue medication

    Time frame: acute phase (within 24 hrs after onset of chemotherapy)

Secondary outcomes

  1. complete response

    Delayed phase means 'from day 2 to day 5' after onset of chemotherapty whole study period means 'from day 1 to day 5' after onset of chemotherapty (acute phase + delayed phase).

    Time frame: during delayed phase and whole study period

07

Study locations

1 of 1 sites recruiting
  • Hyo Jung Kim
    Anyang, Gyeonggi-do 431070, Korea, Republic of
    • Hyo Jung Kim, M.D., Ph.D. · Contact · hemonc@hallym.or.kr · 82313803704
    • Hyo Jung Kim, M.D., Ph.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01536691
Lead sponsor
Hallym University Medical Center
Collaborators
Korean Cancer Study Group, Astellas Pharma Korea, Inc.
Responsible party
Sponsor
First posted
Feb 22, 2012
Start date
Jun 2011
Primary completion
Nov 2012 (estimated)
Completion
Feb 2013 (estimated)
Last update
Oct 3, 2012

Study contacts

Hyo Jung Kim, M.D. Ph.D.
Contact
hemonc@hallym.or.kr
82313803704
Jinjoo Hong, R.N.
Contact
datacenter7@kcsg.org
82232763517
Sangwon Shin, M.D.
principal investigator · Korea University Anam Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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