Chemotherapy-induced Nausea and VomitingPhase 3AOPDPCINVNCT02484911
Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting
A Phase 3 study testing Olanzapine, Aprepitant and Palonosetron in people with Chemotherapy-induced Nausea and Vomiting, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy. 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?
- Olanzapine, Aprepitant and Palonosetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Jan 2017
- Phase
- Phase 3
- 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
Who may be able to join
- 18 years of age or older
- Histologically or cytologically confirmed malignant disease
- Accept chemotherapy for the first time
- Patients who will receive high emetogenic cancer chemotherapy (HEC) (cisplatin>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide>=1500mg/m2,adriamycin>60mg/m2,epirubicin>90mg/m2,dacarbazine，ifosfamide>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin>=300mg/m2,cyclophosphamide>=600-1000mg/m2,adriamycin>50mg/m2)
- Written informed consent
Who cannot join
- Pregnant or breast-feeding
- Uncontrolled psychosis history
- Inability or unwillingness to understand or cooperate with study procedures
- Central nervous system tumors primary or secondary
- Concurrent abdominal radiotherapy
- History of uncontrolled diabetes mellitus
Show all 16Show fewer
- Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.
- Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
- Pre-existing nausea or vomiting
- Inadequate hematological function and abnormal liver and renal function.
- History of sensitivity to olanzapine
- Concurrent application of quinolone antibiotic therapy
- Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
- Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
- Concurrent application of systemic corticosteroids
- Active infection or gastrointestinal dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
About this study
Official title: Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting---A Randomized Single Center Phase III Trial
The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.
Read the detailed description
Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .In the other group,patients will accept the same dose of aprepitant ,palonosetron and dexamethasone .During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Olanzapine, Aprepitant, Palonosetron, Dexamethasone
- Keywords
- chemotherapy nausea vomiting
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
5mg,twice a day orally on day 1 to day 4
AprepitantDrug
125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
PalonosetronDrug
0.25mg IV 30-60min before chemotherapy on day 1
DexamethasoneDrug
6mg IV on day 1 ，3.75mg IV on day 2 to 4
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine regimen | Experimental | Olanzapine in combination with aprepitant ,palonosetron and dexamethasone. Receives: Drug: Olanzapine; Drug: Aprepitant; Drug: Palonosetron; Drug: Dexamethasone |
| Control regimen | Other | Aprepitant in combination with palonosetron and dexamethasone Receives: Drug: Aprepitant; Drug: Palonosetron; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Receiving HEC With Complete Response in Overall Phase
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Measured: 0 to 120 hours
Proportion of Participants Receiving MEC With Complete Response in Overall Phase
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Measured: 0 to 120 hours
Secondary outcomes (10)
Proportion of Participants Receiving HEC With Complete Response in the Acute Phase
Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Measured: 0 to 24 hours
Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase
Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Measured: 24 to 120 hours
Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Measured: 0 to 120 hours
Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase
Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue ）
Measured: 0 to 24 hours
Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase
Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Measured: 24 to 120 hours
Proportion of Participants Receiving MEC With Complete Response in the Acute Phase
Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Measured: 0 to 24 hours
Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase
Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.
Complete response was defined as no vomiting with no rescue therapy.
Measured: 24 to 120 hours
Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase
Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Measured: 0-120 hours
Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase
Overall Phase was defined as 0 to 24 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Measured: 0 to 24 hours
Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase
Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.
No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Measured: 24 to 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2016
- Study completionJan 2017
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.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Harbin Medical University
- Responsible party
- Sponsor
- Investigators
- Daxin Zhang, MD, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484911
- Sponsor's protocol ID
- GHYDZ-1225
- Acronym
- AOPDPCINV
- Status last verified
- Jun 2016
- First submitted
- 22 Jun 2015
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Andrews PL, Naylor RJ, Joss RA. Neuropharmacology of emesis and its relevance to anti-emetic therapy. Consensus and controversies. Support Care Cancer. 1998 May;6(3):197-203. doi: 10.1007/s005200050154.
PubMed 9629870Matsuki N, Torii Y, Saito H. Effects of iron and deferoxamine on cisplatin-induced emesis: further evidence for the role of free radicals. Eur J Pharmacol. 1993 Dec 1;248(4):329-31. doi: 10.1016/0926-6917(93)90008-e.
PubMed 8181539Tattersall FD, Rycroft W, Cumberbatch M, Mason G, Tye S, Williamson DJ, Hale JJ, Mills SG, Finke PE, MacCoss M, Sadowski S, Ber E, Cascieri M, Hill RG, MacIntyre DE, Hargreaves RJ. The novel NK1 receptor antagonist MK-0869 (L-754,030) and its water soluble phosphoryl prodrug, L-758,298, inhibit acute and delayed cisplatin-induced emesis in ferrets. Neuropharmacology. 2000 Feb 14;39(4):652-63. doi: 10.1016/s0028-3908(99)00172-0.
PubMed 10728886Hesketh PJ, Van Belle S, Aapro M, Tattersall FD, Naylor RJ, Hargreaves R, Carides AD, Evans JK, Horgan KJ. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer. 2003 May;39(8):1074-80. doi: 10.1016/s0959-8049(02)00674-3.
PubMed 12736106Grunberg SM, Hesketh PJ. Control of chemotherapy-induced emesis. N Engl J Med. 1993 Dec 9;329(24):1790-6. doi: 10.1056/NEJM199312093292408.
PubMed 8232489Grunberg SM, Slusher B, Rugo HS. Emerging treatments in chemotherapy-induced nausea and vomiting. Clin Adv Hematol Oncol. 2013 Feb;11(2 Suppl 1):1-18; quiz 2 p following 18.
PubMed 23598819Diemunsch P, Grelot L. Potential of substance P antagonists as antiemetics. Drugs. 2000 Sep;60(3):533-46. doi: 10.2165/00003495-200060030-00002.
PubMed 11030465Gao HF, Liang Y, Zhou NN, Zhang DS, Wu HY. Aprepitant plus palonosetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy. Intern Med J. 2013 Jan;43(1):73-6. doi: 10.1111/j.1445-5994.2011.02637.x.
PubMed 22141732Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.
PubMed 19775450Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.
PubMed 22024310
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting---A Randomized Single Center Phase III Trial
- ClinicalTrials.gov ID
- NCT02484911
- Acronym / sponsor ID
- AOPDPCINV / GHYDZ-1225
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- chemotherapy nausea vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Harbin Medical University
- Study start
- May 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Posted 30 Mar 2017
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 the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.
Detailed description
Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .In the other group,patients will accept the same dose of aprepitant ,palonosetron and dexamethasone .During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine regimen | Experimental | Drug: Olanzapine, Drug: Aprepitant, Drug: Palonosetron, Drug: DexamethasoneOlanzapine in combination with aprepitant ,palonosetron and dexamethasone. |
| Control regimen | Other | Drug: Aprepitant, Drug: Palonosetron, Drug: DexamethasoneAprepitant in combination with palonosetron and dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Histologically or cytologically confirmed malignant disease
- Accept chemotherapy for the first time
- Patients who will receive high emetogenic cancer chemotherapy (HEC) (cisplatin>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide>=1500mg/m2,adriamycin>60mg/m2,epirubicin>90mg/m2,dacarbazine，ifosfamide>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin>=300mg/m2,cyclophosphamide>=600-1000mg/m2,adriamycin>50mg/m2)
- Written informed consent
Key exclusion criteria (16 listed)
- Pregnant or breast-feeding
- Uncontrolled psychosis history
- Inability or unwillingness to understand or cooperate with study procedures
- Central nervous system tumors primary or secondary
- Concurrent abdominal radiotherapy
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 |
|---|---|---|
| Olanzapine5mg,twice a day orally on day 1 to day 4 | Drug | Olanzapine regimen |
| Aprepitant125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. | Drug | Control regimen, Olanzapine regimen |
| Palonosetron0.25mg IV 30-60min before chemotherapy on day 1 | Drug | Control regimen, Olanzapine regimen |
| Dexamethasone6mg IV on day 1 ，3.75mg IV on day 2 to 4 | Drug | Control regimen, Olanzapine regimen |
Primary outcome
Proportion of Participants Receiving HEC With Complete Response in Overall Phase
Time frame: 0 to 120 hours
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants Receiving MEC With Complete Response in Overall Phase
Time frame: 0 to 120 hours
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
10 secondary outcomes
Proportion of Participants Receiving HEC With Complete Response in the Acute Phase
Time frame: 0 to 24 hours
Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase
Time frame: 24 to 120 hours
Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase
Time frame: 0 to 120 hours
Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase
Time frame: 0 to 24 hours
Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase
Time frame: 24 to 120 hours
Proportion of Participants Receiving MEC With Complete Response in the Acute Phase
Time frame: 0 to 24 hours
Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase
Time frame: 24 to 120 hours
Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase
Time frame: 0-120 hours
Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase
Time frame: 0 to 24 hours
Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase
Time frame: 24 to 120 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9629870Andrews PL, Naylor RJ, Joss RA. Neuropharmacology of emesis and its relevance to anti-emetic therapy. Consensus and controversies. Support Care Cancer. 1998 May;6(3):197-203. doi: 10.1007/s005200050154.
- Background: PubMed 8181539Matsuki N, Torii Y, Saito H. Effects of iron and deferoxamine on cisplatin-induced emesis: further evidence for the role of free radicals. Eur J Pharmacol. 1993 Dec 1;248(4):329-31. doi: 10.1016/0926-6917(93)90008-e.
- Background: PubMed 10728886Tattersall FD, Rycroft W, Cumberbatch M, Mason G, Tye S, Williamson DJ, Hale JJ, Mills SG, Finke PE, MacCoss M, Sadowski S, Ber E, Cascieri M, Hill RG, MacIntyre DE, Hargreaves RJ. The novel NK1 receptor antagonist MK-0869 (L-754,030) and its water soluble phosphoryl prodrug, L-758,298, inhibit acute and delayed cisplatin-induced emesis in ferrets. Neuropharmacology. 2000 Feb 14;39(4):652-63. doi: 10.1016/s0028-3908(99)00172-0.
- Results publication: PubMed 12736106Hesketh PJ, Van Belle S, Aapro M, Tattersall FD, Naylor RJ, Hargreaves R, Carides AD, Evans JK, Horgan KJ. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer. 2003 May;39(8):1074-80. doi: 10.1016/s0959-8049(02)00674-3.
- Results publication: PubMed 8232489Grunberg SM, Hesketh PJ. Control of chemotherapy-induced emesis. N Engl J Med. 1993 Dec 9;329(24):1790-6. doi: 10.1056/NEJM199312093292408.
- Results publication: PubMed 23598819Grunberg SM, Slusher B, Rugo HS. Emerging treatments in chemotherapy-induced nausea and vomiting. Clin Adv Hematol Oncol. 2013 Feb;11(2 Suppl 1):1-18; quiz 2 p following 18.
- Results publication: PubMed 11030465Diemunsch P, Grelot L. Potential of substance P antagonists as antiemetics. Drugs. 2000 Sep;60(3):533-46. doi: 10.2165/00003495-200060030-00002.
- Results publication: PubMed 22141732Gao HF, Liang Y, Zhou NN, Zhang DS, Wu HY. Aprepitant plus palonosetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy. Intern Med J. 2013 Jan;43(1):73-6. doi: 10.1111/j.1445-5994.2011.02637.x.
- Results publication: PubMed 19775450Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.
- Results publication: PubMed 22024310Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Daxin Zhang, MD principal investigator
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine, Aprepitant and Palonosetron in people with Chemotherapy-induced Nausea and Vomiting, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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 16 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 30 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 1 site in China. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2017). 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?
Proportion of Participants Receiving HEC With Complete Response in Overall Phase (time frame: 0 to 120 hours). 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 NCT02484911, which also lists 10 linked publications.
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 30 Mar 2017.