Lung CancerPhase 2NCT00413283
Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Romiplostim, Gemcitabine and Carboplatin in people with Lung Cancer and Chemotherapy-Induced Thrombocytopenia, run by Amgen at 113 sites in 8 countries.
Trial summary
The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Chemotherapy-Induced Thrombocytopenia, Non-Small Cell Lung Cancer
- What is being tested?
- Romiplostim, Gemcitabine and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 113 sitesin 8 countries
- Study dates
- Dec 2006to Feb 2009
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed locally advanced or metastatic stage IIIB or stage IV NSCLC receiving 21-day cycles of gemcitabine/carboplatin or gemcitabine/cisplatin
- Life expectancy ≥ 12 weeks at the time of screening
- Thrombocytopenia as evidenced by a platelet count ≤ 50 x 10^9/L during the qualifying cycle of chemotherapy, OR platelet count < 100 x 10^9/L on Day 22 of the qualifying cycle (for eligibility inclusion: ability to receive the same dose of chemotherapy on study), this criteria ensures that the patient must be dose delayed for platelet recovery
- Ability to receive the same dose and schedule of chemotherapy during the first on-study treatment cycle as was given in the qualifying cycle (except Day 8 gemcitabine)
- Absolute neutrophil count (ANC) ≥ 1,000/µL, hemoglobin ≥ 9.5 g/dL, and platelet count ≥ 100 x 10 ^9/L on Day 1 of the first on study chemotherapy treatment cycle
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of screening
- Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN) (except for patients with a confirmed diagnosis of Gilbert's Syndrome)
- Adequate renal function; serum creatinine < 1.5 x ULN
Who cannot join
- Receipt of > 1 prior systemic chemotherapy regimen
- Sepsis, disseminated coagulation or any other condition (i.e. immune [idiopathic] thrombocytopenic purpura [ITP], thrombotic thrombocytopenic purpura [TTP], hemolytic uremic syndrome [HUS]) that may exacerbate thrombocytopenia
- History of unstable angina, congestive heart failure, uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year of screening ) myocardial infarction
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening
- History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots)
- Use of any nitrosourea or mitomycin-C within 6 weeks of screening
Show all 11Show fewer
- Have received any thrombopoietic growth factor or related substance
- Have received granulocyte macrophage colony stimulating factor (GM-CSF) within the last 4 weeks prior to screening
- Have received any experimental therapy within 4 weeks prior to screening
- Have ever received a bone marrow or peripheral blood stem cell infusion (within 1 year of screening)
- Known hypersensitivity to any recombinant E. coli-derived product.
Trial locations and contacts
113 sites in 8 countries.
113 sites in 8 countries
United States51 sites
Research Site
Anaheim, California, 92801
Research Site
Anaheim, California
Research Site
Athens, Georgia, 30607
Research Site
Athens, Georgia
Research Site
Austin, Texas, 78705
Research Site
Austin, Texas
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Baltimore, Maryland, 21201
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Baltimore, Maryland
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Billings, Montana, 59101
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Billings, Montana
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Boynton Beach, Florida, 33435
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Boynton Beach, Florida
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Columbia, South Carolina, 29203
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Columbia, South Carolina
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Drexel Hill, Pennsylvania, 19026
Research Site
Drexel Hill, Pennsylvania
Research Site
Dunmore, Pennsylvania, 18512
Research Site
Dunmore, Pennsylvania
Research Site
Flemington, New Jersey, 08822
Research Site
Flemington, New Jersey
Research Site
Germantown, Tennessee, 38138
Research Site
Germantown, Tennessee
Research Site
Glendale, Arizona, 85304
Research Site
Glendale, Arizona
Research Site
Houston, Texas, 77030
Research Site
Houston, Texas, 77074
Research Site
Houston, Texas
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Johnson City, New York, 13790
Research Site
Johnson City, New York
Research Site
Los Angeles, California, 90048
Research Site
Los Angeles, California
Research Site
Macon, Georgia, 31201
Research Site
Macon, Georgia
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Oklahoma City, Oklahoma
Research Site
Paducah, Kentucky, 42003
Research Site
Paducah, Kentucky
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Peoria, Illinois, 61615
Research Site
Peoria, Illinois
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Radnor, Pennsylvania, 19087
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Radnor, Pennsylvania
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Rancho Mirage, California, 92270
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Rancho Mirage, California
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Shreveport, Louisiana, 71101
Research Site
Shreveport, Louisiana
Research Site
Sioux City, Iowa, 51101
Research Site
Sioux City, Iowa
Research Site
Sterling Heights, Michigan, 48314
Research Site
Sterling Heights, Michigan
Research Site
Vero Beach, Florida, 32960
Research Site
Vero Beach, Florida
Hungary17 sites
Research Site
Budapest, 1125
Research Site
Budapest, 1529
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Budapest
Research Site
Edelény, 3780
Research Site
Edelény
Research Site
Gyula, 5703
Research Site
Gyula
Research Site
Mátraháza, 3233
Research Site
Mátraháza
Research Site
Pécs, 7623
Research Site
Pécs
Research Site
Székesfehérvár, 8000
Research Site
Székesfehérvár
Research Site
Törökbálint, 2045
Research Site
Törökbálint
Research Site
Zalaegerszeg - Pozva, 8900
Research Site
Zalaegerszeg - Pozva
Austria12 sites
Research Site
Graz, 8036
Research Site
Graz
Research Site
Innsbruck, 6020
Research Site
Innsbruck
Research Site
Klagenfurt, 9026
Research Site
Klagenfurt
Research Site
Linz, 4010
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Linz
Research Site
Rankweil, 6830
Research Site
Rankweil
Research Site
Vienna, 1090
Research Site
Vienna
Germany8 sites
Research Site
Bad Berka, 99437
Research Site
Bad Berka
Research Site
Dresden, 01307
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Dresden
Research Site
Halle, 06120
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Halle
Research Site
Hemer, 58675
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Hemer
Italy8 sites
Research Site
Novara, 28100
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Novara
Research Site
Orbassano, 10043
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Orbassano
Research Site
Palermo, 90126
Research Site
Palermo
Research Site
Torino, 10126
Research Site
Torino
Portugal8 sites
Research Site
Coimbra, 3040-316
Research Site
Coimbra
Research Site
Lisbon, 1649-035
Research Site
Lisbon
Research Site
Porto, 4200-072
Research Site
Porto
Research Site
Vila Nova de Gaia, 4430-502
Research Site
Vila Nova de Gaia
Ireland5 sites
Research Site
Cork, Cork
Research Site
Cork
Research Site
Dublin, 4
Research Site
Dublin, 8
Research Site
Dublin
Canada4 sites
Research Site
Sainte-Foy, Quebec, G1V 4G5
Research Site
Sainte-Foy, Quebec
Research Site
Toronto, Ontario, M5G 2M9
Research Site
Toronto, Ontario
About this study
Official title: Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 For Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum.
The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.
- Conditions
- Lung Cancer, Chemotherapy-Induced Thrombocytopenia, Non-Small Cell Lung Cancer, Cancer, Lung Neoplasms, Oncology
- Being tested
- Romiplostim, Placebo, Gemcitabine, Carboplatin, Cisplatin
- Keywords
- Advanced Non-Small Cell Lung Cancer, Chemotherapy Induced Thrombocytopenia, CIT, NSCLC, Stage IIIB NSCLC, Stage IV NSCLC, Gemcitabine, Carboplatin, Cisplatin
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomiplostimBiological
Also called AMG 531, Nplate®
Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.
PlaceboDrug
Placebo subcutaneous injection.
GemcitabineDrug
Intravenous infusion
CarboplatinDrug
Intravenous infusion
CisplatinDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. Receives: Drug: Placebo; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin |
| Romiplostim 250 μg | Experimental | Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. Receives: Biological: Romiplostim; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin |
| Romiplostim 500 μg | Experimental | Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. Receives: Biological: Romiplostim; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin |
| Romiplostim 750 μg | Experimental | Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. Receives: Biological: Romiplostim; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.
Measured: 4 months
Secondary outcomes (5)
Duration of Grade 3 or 4 Thrombocytopenia
The duration of grade 3 or 4 thrombocytopenia (defined as platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group.
Measured: 3 weeks
Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.
The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count < 50 x 10^9/L, but ≥ 25 x 10^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count < 25 x 10^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.
Measured: 3 weeks
Number of Participants With Platelet Transfusions
Number of participants who were administered platelet transfusions during first on study treatment cycle.
Measured: 3 weeks
Platelet Count on Day 22
Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group
Measured: Day 22
Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle
Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2008
- Study completionFeb 2009
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413283
- Sponsor's protocol ID
- 20050154
- Status last verified
- Sep 2013
- First submitted
- 15 Dec 2006
- Last updated
- 24 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 For Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum.
- ClinicalTrials.gov ID
- NCT00413283
- Acronym / sponsor ID
- 20050154
- Conditions
- Lung Cancer, Chemotherapy-Induced Thrombocytopenia, Non-Small Cell Lung Cancer, Cancer, Lung Neoplasms, Oncology
- Keywords
- Advanced Non-Small Cell Lung Cancer, Chemotherapy Induced Thrombocytopenia, CIT, NSCLC, Stage IIIB NSCLC, Stage IV NSCLC, Gemcitabine, Carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Posted 21 Oct 2010
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 this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: Gemcitabine, Drug: Carboplatin, Drug: CisplatinParticipants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. |
| Romiplostim 250 μg | Experimental | Biological: Romiplostim, Drug: Gemcitabine, Drug: Carboplatin, Drug: CisplatinParticipants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. |
| Romiplostim 500 μg | Experimental | Biological: Romiplostim, Drug: Gemcitabine, Drug: Carboplatin, Drug: CisplatinParticipants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. |
| Romiplostim 750 μg | Experimental | Biological: Romiplostim, Drug: Gemcitabine, Drug: Carboplatin, Drug: CisplatinParticipants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed locally advanced or metastatic stage IIIB or stage IV NSCLC receiving 21-day cycles of gemcitabine/carboplatin or gemcitabine/cisplatin
- Life expectancy ≥ 12 weeks at the time of screening
- Thrombocytopenia as evidenced by a platelet count ≤ 50 x 10^9/L during the qualifying cycle of chemotherapy, OR platelet count < 100 x 10^9/L on Day 22 of the qualifying cycle (for eligibility inclusion: ability to receive the same dose of chemotherapy on study), this criteria ensures that the patient must be dose delayed for platelet recovery
- Ability to receive the same dose and schedule of chemotherapy during the first on-study treatment cycle as was given in the qualifying cycle (except Day 8 gemcitabine)
- Absolute neutrophil count (ANC) ≥ 1,000/µL, hemoglobin ≥ 9.5 g/dL, and platelet count ≥ 100 x 10 ^9/L on Day 1 of the first on study chemotherapy treatment cycle
Key exclusion criteria (11 listed)
- Receipt of > 1 prior systemic chemotherapy regimen
- Sepsis, disseminated coagulation or any other condition (i.e. immune [idiopathic] thrombocytopenic purpura [ITP], thrombotic thrombocytopenic purpura [TTP], hemolytic uremic syndrome [HUS]) that may exacerbate thrombocytopenia
- History of unstable angina, congestive heart failure, uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year of screening ) myocardial infarction
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening
- History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots)
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 |
|---|---|---|
| RomiplostimAlso: AMG 531, Nplate®Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. | Biological | Romiplostim 250 μg, Romiplostim 500 μg, Romiplostim 750 μg |
| PlaceboPlacebo subcutaneous injection. | Drug | Placebo |
| GemcitabineIntravenous infusion | Drug | Placebo, Romiplostim 250 μg, Romiplostim 500 μg, Romiplostim 750 μg |
| CarboplatinIntravenous infusion | Drug | Placebo, Romiplostim 250 μg, Romiplostim 500 μg, Romiplostim 750 μg |
| CisplatinIntravenous infusion | Drug | Placebo, Romiplostim 250 μg, Romiplostim 500 μg, Romiplostim 750 μg |
Primary outcome
Number of Participants With Adverse Events
Time frame: 4 months
This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.
5 secondary outcomes
Duration of Grade 3 or 4 Thrombocytopenia
Time frame: 3 weeks
Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.
Time frame: 3 weeks
Number of Participants With Platelet Transfusions
Time frame: 3 weeks
Platelet Count on Day 22
Time frame: Day 22
Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle
Time frame: 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink 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.
MD study director
Amgen
113 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Romiplostim, Gemcitabine and Carboplatin in people with Lung Cancer and Chemotherapy-Induced Thrombocytopenia, run by Amgen at 113 sites in 8 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 8 inclusion and 11 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 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in United States, Hungary, Austria, Germany, Italy and 3 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Oct 2010). 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?
Number of Participants With Adverse Events (time frame: 4 months). 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 24 Oct 2013.