Chemotherapy-induced Nausea and VomitingNCT01074255
Re-examination Study of EMEND (Aprepitant) (MK-0869-184)
An observational study of Chemotherapy-induced Nausea and Vomiting, run by Merck Sharp & Dohme LLC.
Trial summary
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- EMEND
- Type of treatment
- Pill or oral medicine
- How many people
- 3,546 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Oct 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean patients treated with EMEND in usual practice.
Who may be able to join
- Participants who are treated with EMEND for the first time as per the EMEND label
Who cannot join
- Contraindication to EMEND
About this study
Official title: Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- EMEND
- Keywords
- Nausea, Vomiting, Chemotherapy, Post-chemotherapy
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMENDDrug
Also called Aprepitant, MK-0869
EMEND (Aprepitant,125 mg oral capsules) is administered 1 hour prior to chemotherapy on treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
| Study group | Role | What they receive |
|---|---|---|
| Korean Participants Treated With EMEND (aprepitant) | Participants receiving EMEND on Treatment Days 1, 2, and 3 concomitantly with a corticosteroid and a 5-hydroxytryptamine 3 (5-HT3) antagonist. Receives: Drug: EMEND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy
The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect).
Measured: Up to 14 days following the cessation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startApr 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074255
- Sponsor's protocol ID
- 0869-184
- Other IDs
- MK-0869-184
- Status last verified
- Apr 2015
- First submitted
- 22 Feb 2010
- Last updated
- 21 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice
- ClinicalTrials.gov ID
- NCT01074255
- Acronym / sponsor ID
- 0869-184
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Nausea, Vomiting, Chemotherapy, Post-chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,546 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Posted 5 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Korean Participants Treated With EMEND (aprepitant) | – | Drug: EMENDParticipants receiving EMEND on Treatment Days 1, 2, and 3 concomitantly with a corticosteroid and a 5-hydroxytryptamine 3 (5-HT3) antagonist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean patients treated with EMEND in usual practice.
Key inclusion criteria (1 listed)
- Participants who are treated with EMEND for the first time as per the EMEND label
Key exclusion criteria (1 listed)
- Contraindication to EMEND
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 |
|---|---|---|
| EMENDAlso: Aprepitant, MK-0869EMEND (Aprepitant,125 mg oral capsules) is administered 1 hour prior to chemotherapy on treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist. | Drug | Korean Participants Treated With EMEND (aprepitant) |
Primary outcome
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy
Time frame: Up to 14 days following the cessation of treatment
The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Nausea and Vomiting, run by Merck Sharp & Dohme LLC.
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 1 inclusion and 1 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 5 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy (time frame: Up to 14 days following the cessation of treatment). 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 21 Apr 2015.