VomitingPhase 3NCT00272285
A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea
A Phase 3 study testing Ramosetron and Granisetron in people with Vomiting and Nausea, run by Astellas Pharma Inc at 2 sites in Taiwan.
Trial summary
The purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- What is being tested?
- Ramosetron and Granisetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2006to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with age between 20-74 years old (inclusive) of either sex
- Cancer subject is scheduled to receive the designated chemotherapy programs
- Subject without symptoms of vomiting for at least one week before dosing trial medication
- Subject with ECOG performance status scale no greater than 2
- Subject has signed the written informed consent form
Who cannot join
- Subject has received radiotherapy to the abdomen or pelvis within 4 weeks before entering this study
- Subject has received the designated chemotherapy programs within 6 months before entering the study
- Subject has known heart failure or myocardial infraction or with laboratory abnormalities at screening
- Subject has known concurrent diseases that may cause vomiting
- Subject has taken medications that could influence the outcome of the study within 3 days before entering the study
- Subject with a history of allergy or intolerance to ramosetron, granisetron or dexamethasone
Show all 9Show fewer
- Female subject who is pregnant or breastfeeding
- Subject with life expectancy less than 3 months
- Subject participated other investigational drug trial within 1 month before entering this study
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Double-blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of Ramosetron Plus Dexamethasone Injection for the Prevention of Chemotherapy-Induced Vomiting and Nausea
The purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea.
- Being tested
- Ramosetron, Granisetron
- Keywords
- Serotonin antagonists, Randomized controlled trial, Combination drug therapy, Double-blind method
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamosetronDrug
IV, concomitant administration with dexamethasone
GranisetronDrug
IV, concomitant administration with dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intravenous (IV) Receives: Drug: Ramosetron |
| 2 | Active comparator | Intravenous (IV) Receives: Drug: Granisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients without vomiting after the start of chemotherapy for 24 hours
Measured: 1 Day
Secondary outcomes (3)
Response rate of vomiting prevention
Measured: 1 Day
The number of vomiting episodes
Measured: 1 Day
The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Responsible party
- Sponsor
- Investigators
- Use central contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272285
- Sponsor's protocol ID
- 06003/TnIO01
- Status last verified
- Mar 2017
- First submitted
- 3 Jan 2006
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of Ramosetron Plus Dexamethasone Injection for the Prevention of Chemotherapy-Induced Vomiting and Nausea
- ClinicalTrials.gov ID
- NCT00272285
- Acronym / sponsor ID
- 06003/TnIO01
- Keywords
- Serotonin antagonists, Randomized controlled trial, Combination drug therapy, Double-blind method
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 5 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RamosetronIntravenous (IV) |
| 2 | Active comparator | Drug: GranisetronIntravenous (IV) |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with age between 20-74 years old (inclusive) of either sex
- Cancer subject is scheduled to receive the designated chemotherapy programs
- Subject without symptoms of vomiting for at least one week before dosing trial medication
- Subject with ECOG performance status scale no greater than 2
- Subject has signed the written informed consent form
Key exclusion criteria (9 listed)
- Subject has received radiotherapy to the abdomen or pelvis within 4 weeks before entering this study
- Subject has received the designated chemotherapy programs within 6 months before entering the study
- Subject has known heart failure or myocardial infraction or with laboratory abnormalities at screening
- Subject has known concurrent diseases that may cause vomiting
- Subject has taken medications that could influence the outcome of the study within 3 days before entering the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamosetronIV, concomitant administration with dexamethasone | Drug | 1 |
| GranisetronIV, concomitant administration with dexamethasone | Drug | 2 |
Primary outcome
Proportion of patients without vomiting after the start of chemotherapy for 24 hours
Time frame: 1 Day
3 secondary outcomes
Response rate of vomiting prevention
Time frame: 1 Day
The number of vomiting episodes
Time frame: 1 Day
The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS)
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use central contact study chair
Astellas Pharma Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramosetron and Granisetron in people with Vomiting and Nausea, run by Astellas Pharma Inc at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients without vomiting after the start of chemotherapy for 24 hours (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.