NauseaPhase 4NCT00092183
An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)
A Phase 4 study testing MK0869, aprepitant / Duration of Treatment: 3 days and Comparator: ondansetron / Duration of Treatment: 3 days in people with Nausea and Vomiting, run by Merck Sharp & Dohme LLC.
Trial summary
This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea, Vomiting, Breast Neoplasms
- What is being tested?
- MK0869, aprepitant / Duration of Treatment: 3 days and Comparator: ondansetron / Duration of Treatment: 3 days
- How many people
- 866 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2002to 11 Feb 2004
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.
Who cannot join
- Patient has a central nervous system malignancy.
- Patient will receive radiation to the abdomen or pelvis.
About this study
Official title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy
This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.
- Conditions
- Nausea, Vomiting, Breast Neoplasms
- Being tested
- MK0869, aprepitant / Duration of Treatment: 3 days, Comparator: ondansetron / Duration of Treatment: 3 days
- Keywords
- Chemotherapy-Induced Nausea and Vomiting
- Medical subject headings
- Nausea, Vomiting, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0869, aprepitant / Duration of Treatment: 3 daysDrug
Comparator: ondansetron / Duration of Treatment: 3 daysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Emesis and use of rescue medication
Safety and tolerability
Secondary outcomes (1)
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2004 (estimated)
- Study start10 Oct 2002
- Primary completion1 Dec 2003
- Study completion11 Feb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 866 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
- NCT00092183
- Sponsor's protocol ID
- 0869-071
- Other IDs
- MK0869-071, 2004_063
- Status last verified
- May 2017
- First submitted
- 21 Sep 2004
- Last updated
- 5 May 2017
- Results posted
- No
Publications
Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005 Apr 20;23(12):2822-30. doi: 10.1200/JCO.2005.09.050.
PubMed 15837996
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT00092183
- Acronym / sponsor ID
- 0869-071
- Conditions
- Nausea, Vomiting, Breast Neoplasms
- Keywords
- Chemotherapy-Induced Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 866 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2002 (actual)
- Primary completion
- 1 Dec 2003 (actual)
- Study completion
- 11 Feb 2004 (actual)
- First posted
- 24 Sep 2004 (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 protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.
Key exclusion criteria (2 listed)
- Patient has a central nervous system malignancy.
- Patient will receive radiation to the abdomen or pelvis.
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 |
|---|---|---|
| MK0869, aprepitant / Duration of Treatment: 3 days | Drug | – |
| Comparator: ondansetron / Duration of Treatment: 3 days | Drug | – |
Primary outcome
Emesis and use of rescue medication
Safety and tolerability
1 secondary outcome
Quality of life
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 5 May 2017.
- Background: PubMed 15837996Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005 Apr 20;23(12):2822-30. doi: 10.1200/JCO.2005.09.050.
Related trials for Nausea
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
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?
A Phase 4 study testing MK0869, aprepitant / Duration of Treatment: 3 days and Comparator: ondansetron / Duration of Treatment: 3 days in people with 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 2 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 5 May 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Emesis and use of rescue medication. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00092183, which also lists 1 linked publication.
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 5 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.