Colon CancerNCT02076529
Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting
A study testing Ramosetron 0.3mg, Ramosetron 0.45mg and Ramosetron 0.6mg in people with Colon Cancer, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
This study is designted to know optimal dose of Ramosteron to control for chemotherapy induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using Rhodes Index. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Ramosetron 0.3mg, Ramosetron 0.45mg and Ramosetron 0.6mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Dec 2013
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who recevied moderate emetogenic chemotherapy
- Age between 18-75
- ECOG PS 0-2
- Adequate organ fuction including bone marrow, liver and kidney
Who cannot join
- Gastrointestinal obstruction or carcinomatosis peritonei
- CNS metastasis or disability in CNS
- Intractable medical illness
- Pregnancy or inadequate contraception
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hwasun Hospital
Gwangju, Jeollanamdo, 519-809
About this study
Official title: A Study About Pharmacokinetic and Pharmacodynamics of Ramosetron in Chemotherapy Induced Nausea and Vomiting
This study is designted to know optimal dose of Ramosteron to control for chemotherapy induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using Rhodes Index.
Read the detailed description
Nausea and vomiting is a common adverse event during chemotherapy treatment. Even if preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor antagonist, has been developed and used, there is residual nausea and/or vomiting in a significant percentage of patients treated for cancer. Serotonin receptor antagonist is the most potent antiemetic agent and has been used widely. However, the optimal dose of serotonin antagnosit based on individual symptoms is not defined. Therefore, this study was conducted to design standardization model for optiomal serotonin antagonist concentration using pharmacodynamic study and Rhodes Index as a suggogate marker for CINV.
- Conditions
- Colon Cancer
- Being tested
- Ramosetron 0.3mg, Ramosetron 0.45mg, Ramosetron 0.6mg
- Keywords
- chemotherapy induced nausea vomiting
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramosetron 0.3mgDrug
Also called Nasea 0.3mg
Ramosetron 0.45mgDrug
Also called Nasea 0.45mg
Ramosetron 0.6mgDrug
Also called Nasea 0.6mg
| Study group | Role | What they receive |
|---|---|---|
| Ramosetron 0.6mg | Experimental | Ramosetron 0.6mg intravenous injection 30min before chemotherapy Receives: Drug: Ramosetron 0.6mg |
| Ramosetron 0.45mg | Experimental | Ramosetron 0.45mg intravenous injection 30min before chemotherapy Receives: Drug: Ramosetron 0.45mg |
| Ramosetron 0.3mg | Active comparator | Ramosetron 0.3mg intravenous injection 30 min before chemotherapy Receives: Drug: Ramosetron 0.3mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of Ramosetron according to 3 level of dose
Pharmacokinectics using NONMEM will be analyzed from serum after Ramosetron injection from 10 min to 48 hours (10min, 1hr, 6hr, 24hr, 48hr)
Measured: 10min to 48 hours post-dose
Secondary outcomes (1)
Rhodes Index
Monitor using Rhodes Index will be performed each time at 1hour, 6hour, 24hour, 48hour and seven dyas after Ramosetron injection
Measured: 1 hour to seven days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Hee Cho, Chonnam National University Hospital
- Investigators
- Sang-Hee Cho, M.D.Ph.D., Principal investigator, CNUHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076529
- Sponsor's protocol ID
- RamosetronPK
- Status last verified
- Feb 2014
- First submitted
- 28 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study About Pharmacokinetic and Pharmacodynamics of Ramosetron in Chemotherapy Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT02076529
- Acronym / sponsor ID
- RamosetronPK
- Conditions
- Colon Cancer
- Keywords
- chemotherapy induced nausea vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Mar 2014 (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.
This study is designted to know optimal dose of Ramosteron to control for chemotherapy induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using Rhodes Index.
Detailed description
Nausea and vomiting is a common adverse event during chemotherapy treatment. Even if preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor antagonist, has been developed and used, there is residual nausea and/or vomiting in a significant percentage of patients treated for cancer. Serotonin receptor antagonist is the most potent antiemetic agent and has been used widely. However, the optimal dose of serotonin antagnosit based on individual symptoms is not defined. Therefore, this study was conducted to design standardization model for optiomal serotonin antagonist concentration using pharmacodynamic study and Rhodes Index as a suggogate marker for CINV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ramosetron 0.6mg | Experimental | Drug: Ramosetron 0.6mgRamosetron 0.6mg intravenous injection 30min before chemotherapy |
| Ramosetron 0.45mg | Experimental | Drug: Ramosetron 0.45mgRamosetron 0.45mg intravenous injection 30min before chemotherapy |
| Ramosetron 0.3mg | Active comparator | Drug: Ramosetron 0.3mgRamosetron 0.3mg intravenous injection 30 min before chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who recevied moderate emetogenic chemotherapy
- Age between 18-75
- ECOG PS 0-2
- Adequate organ fuction including bone marrow, liver and kidney
Key exclusion criteria (4 listed)
- Gastrointestinal obstruction or carcinomatosis peritonei
- CNS metastasis or disability in CNS
- Intractable medical illness
- Pregnancy or inadequate contraception
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 |
|---|---|---|
| Ramosetron 0.3mgAlso: Nasea 0.3mg | Drug | Ramosetron 0.3mg |
| Ramosetron 0.45mgAlso: Nasea 0.45mg | Drug | Ramosetron 0.45mg |
| Ramosetron 0.6mgAlso: Nasea 0.6mg | Drug | Ramosetron 0.6mg |
Primary outcome
Pharmacokinetic profile of Ramosetron according to 3 level of dose
Time frame: 10min to 48 hours post-dose
Pharmacokinectics using NONMEM will be analyzed from serum after Ramosetron injection from 10 min to 48 hours (10min, 1hr, 6hr, 24hr, 48hr)
1 secondary outcome
Rhodes Index
Time frame: 1 hour to seven days post-dose
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 3 Mar 2014.
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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.
Sang-Hee Cho, M.D.Ph.D. principal investigator
CNUHH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ramosetron 0.3mg, Ramosetron 0.45mg and Ramosetron 0.6mg in people with Colon Cancer, run by Chonnam National University Hospital at 1 site in South Korea.
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 4 inclusion and 4 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 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
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?
Pharmacokinetic profile of Ramosetron according to 3 level of dose (time frame: 10min to 48 hours post-dose). 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 3 Mar 2014.