Nausea and VomitingPhase 2NCT00169572
Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy
A Phase 2 study testing Aprepitant, Ondansetron and GW679769 in people with Nausea and Vomiting and Chemotherapy-Induced, run by GlaxoSmithKline at 51 sites in 19 countries.
Trial summary
This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea and Vomiting, Chemotherapy-Induced
- What is being tested?
- Aprepitant, Ondansetron and GW679769
- How many people
- 492 participants
- Where
- 51 sitesin 19 countries
- Study dates
- Feb 2005to not given
- Phase
- Phase 2
- 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
- Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- Diagnosed with a solid malignant tumour and has not previously received chemotherapy.
- Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.
Who cannot join
- Not received any investigational product within 30 days of enrolment into the study.
- Must not be pregnant.
- Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
- Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
- Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
- Must not have a history of peptic ulcer disease.
Trial locations and contacts
51 sites in 19 countries.
51 sites in 19 countries
Italy8 sites
GSK Investigational Site
Benevento, Campania, 82100
GSK Investigational Site
Casalpusterlengo (LO), Lombardy, 26841
GSK Investigational Site
Naples, Campania, 80131
GSK Investigational Site
Perugia, Umbria, 06156
GSK Investigational Site
Pisa, Tuscany, 56124
GSK Investigational Site
Rome, Lazio, 00149
GSK Investigational Site
Rome, Lazio, 00184
GSK Investigational Site
Sassari, Sardinia, 07100
Czechia5 sites
GSK Investigational Site
Hradec Králové, 500 05
GSK Investigational Site
Ostrava - Poruba, 708 52
GSK Investigational Site
Prague, 12808
GSK Investigational Site
Prague, 154 00
GSK Investigational Site
Prague, 180 81
Netherlands5 sites
GSK Investigational Site
Amsterdam, 1066 CX
GSK Investigational Site
Amsterdam, 1081 HV
GSK Investigational Site
Arnhem, 6815 AD
GSK Investigational Site
Rotterdam, 3045 PM
GSK Investigational Site
Utrecht, 3527 CE
Belgium4 sites
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4020
Poland4 sites
GSK Investigational Site
Bydogoszcz, 85-796
GSK Investigational Site
Krakow, 31-115
GSK Investigational Site
Poznan, 60-569
GSK Investigational Site
Poznan, 61-866
Austria3 sites
GSK Investigational Site
Salzburg, A-5020
GSK Investigational Site
Vienna, A-1090
GSK Investigational Site
Vienna, A-1130
Taiwan3 sites
GSK Investigational Site
Taipei, 112
GSK Investigational Site
Taipei, 114
GSK Investigational Site
Tao Yuan County, 333
Argentina2 sites
GSK Investigational Site
Buenos Aires, C1405CBA
GSK Investigational Site
Capital Federal, Buenos Aires, C1437JCP
Chile2 sites
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500921
GSK Investigational Site
Santiago, Región Metro de Santiago
Hungary2 sites
GSK Investigational Site
Budapest, 1529
GSK Investigational Site
Székesfehérvár, 8000
Mexico2 sites
GSK Investigational Site
Durango, Durango, 34000
GSK Investigational Site
Mérida, Yucatán, 97500
Pakistan2 sites
GSK Investigational Site
Karachi, 54000
GSK Investigational Site
Lahore
Philippines2 sites
GSK Investigational Site
Quezon City, 1101
GSK Investigational Site
Taft Avenue, Manila, 1700
Slovakia2 sites
GSK Investigational Site
Košice, 041 90
GSK Investigational Site
Nitra, 949 88
Peru1 site
GSK Investigational Site
Callao, Provincia Constitucional del Callao, Callao 1
About this study
Official title: See Detailed Description
This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.
Read the detailed description
Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.
- Conditions
- Nausea and Vomiting, Chemotherapy-Induced
- Being tested
- Aprepitant, Ondansetron, GW679769, Dexamethasone
- Keywords
- Nausea, Vomiting, Emesis, Chemotherapy-induced Nausea and Vomiting, CINV
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
OndansetronDrug
GW679769Drug
DexamethasoneDrug
Also called Aprepitant, Ondansetron, GW679769
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
Secondary outcomes (1)
Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 492 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169572
- Sponsor's protocol ID
- NKV20001
- Status last verified
- May 2010
- First submitted
- 9 Sep 2005
- Last updated
- 10 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- See Detailed Description
- ClinicalTrials.gov ID
- NCT00169572
- Acronym / sponsor ID
- NKV20001
- Conditions
- Nausea and Vomiting, Chemotherapy-Induced
- Keywords
- Nausea, Vomiting, Emesis, Chemotherapy-induced Nausea and Vomiting, CINV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- First posted
- 15 Sep 2005 (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 was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.
Detailed description
Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- Diagnosed with a solid malignant tumour and has not previously received chemotherapy.
- Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.
Key exclusion criteria (6 listed)
- Not received any investigational product within 30 days of enrolment into the study.
- Must not be pregnant.
- Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
- Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
- Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
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 |
|---|---|---|
| Aprepitant | Drug | – |
| Ondansetron | Drug | – |
| GW679769 | Drug | – |
| DexamethasoneAlso: Aprepitant, Ondansetron, GW679769 | Drug | – |
Primary outcome
The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
1 secondary outcome
Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.
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 10 May 2010.
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
51 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aprepitant, Ondansetron and GW679769 in people with Nausea and Vomiting and Chemotherapy-Induced, run by GlaxoSmithKline at 51 sites in 19 countries.
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 3 inclusion and 6 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 10 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Italy, Czechia, Netherlands, Belgium, Poland and 14 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.. 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 10 May 2010.