AsthmaPhase 2NCT00590720
A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma
A Phase 2 study testing MEDI528 50 mg in people with Asthma, run by MedImmune LLC at 12 sites in 2 countries.
Trial summary
The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- MEDI528 50 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Mar 2008to Oct 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must meet all of the following criteria:
- Male or female adults, age 18 through 50 years at the time of screening;
- Weight 50-100 kg and body mass index ≤ 35;
- Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
- Documented clinical history of asthma and receiving stable treatment for ≥ 1 month prior to Study Day 0;
- Airway hyperresponsiveness (AHR) on methacholine inhalation challenge testing at screening (or a documented history within the past 6 months), with provoking concentration of methacholine to cause a 20% fall in FEV1(subscript) (PC20) ≤ 8 mg/mL (Crapo, 2000);
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- Exercise-induced bronchoconstriction (EIB) with a decrease in FEV1 (subscript) of ≥ 15% from pre-exercise challenge testing level at screening;
- Able to provide spirometry readings that meet American Thoracic Society (ATS) and European Respiratory Society (ERS) standards (Miller, 2005);
- Women of childbearing potential, unless surgically sterile or at least 1 year post-menopausal, must use two effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom, spermicide, diaphragm, cervical cap, abstinence, contraceptive foam, or use of a condom by the sexual partner or sterile sexual partner) from screening through Study Day 0, and must agree to continue using such precautions through Study Day 150. Cessation of birth control after this point should be discussed with a responsible physician. Men, unless surgically sterile, must likewise use an effective method of birth control (condom with spermicide) and must agree to continue using such precautions from screening through Study Day 150;
- Able to complete the study period, including follow-up period, of up to approximately 150 days; and
- Willing to forego other forms of experimental treatment and study procedures during the study and for 30 days after the follow-up period is completed.
Who cannot join
- Patients must have none of the following criteria:
- Receipt of MEDI-528 in any previous clinical study;
- History of allergy or reaction to any component of the study drug formulation;
- Lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis);
- Forced expiratory volume in 1 second (FEV1-subscript) < 70% of predicted values at screening;
- Use of systemic immunosuppressive drugs including systemic corticosteroids, ICS with doses > 800 μg/day budesonide (or another ICS of equivalent dose), long-acting β2 agonists, cromolyn sodium, nedocromil sodium, leukotriene receptor antagonists, theophylline, or omalizumab from screening through Study Day 150;
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- Current use of any β-adrenergic antagonist (eg, propranolol);
- Any disease or illness, other than asthma, that is likely to require the use of systemic corticosteroids during the study period;
- Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) from screening through Study Day 0;
- Current allergy vaccination therapy (desensitization immunotherapy);
- Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to screening;
- Pregnancy (women of child bearing potential, unless surgically sterile or at least 1 year postmenopausal, must have a negative serum and urine pregnancy test at screening before methacholine inhalation challenge testing and a negative urine pregnancy test prior to study drug administration on Study Day 0);
- Breastfeeding or lactating woman;
- Evidence of infection with hepatitis B or C virus or HIV-1 or HIV-2, or active infection with hepatitis A; must have negative HIV-1, HIV-2, hepatitis A, B, and C tests at screening;
- History of cancer other than basal cell carcinoma of the skin or cervical carcinoma-in-situ treated with apparent success with curative therapy more than 1 year prior to Study Day 0;
- History of primary immunodeficiency
- History of pancreatitis or currently active gastroduodenal ulcer;
- Current use of tobacco products or a history of use of tobacco products of more than one cigarette per month or equivalent within 1 year prior to randomization or history of smoking of ≥ 10 pack-years;
- History of life-long urinary retention;
- History of anaphylaxis (defined as immediate life-threatening event requiring medical invention);
- Elective surgery planned from screening through Study Day 150;
- Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at screening;
- History of any disease, evidence of any current disease (other than asthma), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study; or
- Any employee of the research site who is involved with the conduct of the study.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
National Jewish Medical and Research Center
Denver, Colorado, 80206
Northeast Medical Research Associates, Inc
No. Dartmouth, Massachusetts, 02747
Sneeze,Wheeze & Itch Associates, LLC
Normal, Illinois, 61761
Creighton University
Omaha, Nebraska, 68131
Institute of Healthcare Assessment, Inc
San Diego, California, 92120
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Univ. of South Florida, Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, 33613
Waterbury Pulmonary Associates
Waterbury, Connecticut, 06708
Canada3 sites
Calgary COPD & Asthma Program
Calgary, Alberta, T2N4N1
Centre de Recherche Appliquee en Allergie de Quebec
Québec, Quebec, G1V4M6
UHN- Toronto Western Hospital
Toronto, Ontario, M5T2S8
About this study
Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Effect on Exercise Challenge Testing of Multiple Fixed Subcutaneous Doses of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody, in Adults With Stable Asthma and Exercise-Induced Bronchoconstriction
The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of multiple fixed escalating SC doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).
- Conditions
- Asthma
- Being tested
- MEDI528 50 mg, PLACEBO
- Keywords
- Asthma, Bronchitis
- Medical subject headings
- Asthma, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI528 50 mgBiological
MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
PLACEBOOther
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| MEDI528 50 mg | Experimental | MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks Receives: Biological: MEDI528 50 mg |
| PLACEBO | Placebo comparator | Placebo administered as a subcutaneous injection twice weekly for 4 weeks Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Measured: Days 0 - 150
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Measured: Days 0 - 150
Secondary outcomes (17)
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Number of participants with ADA to MEDI-528
Measured: Days 0, 28, 56, 119, and 150
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.
Measured: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.
Measured: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.
Measured: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.
Measured: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.
Measured: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.
Measured: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
AUC of FEV1 at Day 28
Measured: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
AUC of FEV1 at Day 56
Measured: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
AUC of FEV1 at Day 150
Measured: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28
Measured: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56
Measured: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150
Measured: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Mean Trough Concentration (Cmin)
Cmin of MEDI-528
Measured: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150
Mean Trough Concentration at Last Measurable Time Point (Cmin_last)
Cmin_last of MEDI-528
Measured: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150
Half-life (T1/2)
T1/2 of MEDI-528
Measured: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150
Accumulation Index
Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528
Measured: Days 0 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionOct 2009
Why it stopped: Study is replaced by MI-CP198 per CPM.
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 (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Parker, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590720
- Sponsor's protocol ID
- MI-CP143
- Status last verified
- Feb 2014
- First submitted
- 26 Dec 2007
- Last updated
- 21 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Parker JM, Oh CK, LaForce C, Miller SD, Pearlman DS, Le C, Robbie GJ, White WI, White B, Molfino NA; MEDI-528 Clinical Trials Group. Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma. BMC Pulm Med. 2011 Feb 28;11:14. doi: 10.1186/1471-2466-11-14.
PubMed 21356110
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Effect on Exercise Challenge Testing of Multiple Fixed Subcutaneous Doses of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody, in Adults With Stable Asthma and Exercise-Induced Bronchoconstriction
- ClinicalTrials.gov ID
- NCT00590720
- Acronym / sponsor ID
- MI-CP143
- Conditions
- Asthma
- Keywords
- Asthma, Bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study is replaced by MI-CP198 per CPM.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 21 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of multiple fixed escalating SC doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI528 50 mg | Experimental | Biological: MEDI528 50 mgMEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks |
| PLACEBO | Placebo comparator | Other: PLACEBOPlacebo administered as a subcutaneous injection twice weekly for 4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female adults, age 18 through 50 years at the time of screening;
- Weight 50-100 kg and body mass index ≤ 35;
- Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
- Documented clinical history of asthma and receiving stable treatment for ≥ 1 month prior to Study Day 0;
- Airway hyperresponsiveness (AHR) on methacholine inhalation challenge testing at screening (or a documented history within the past 6 months), with provoking concentration of methacholine to cause a 20% fall in FEV1(subscript) (PC20) ≤ 8 mg/mL (Crapo, 2000);
Key exclusion criteria (24 listed)
- Receipt of MEDI-528 in any previous clinical study;
- History of allergy or reaction to any component of the study drug formulation;
- Lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis);
- Forced expiratory volume in 1 second (FEV1-subscript) < 70% of predicted values at screening;
- Use of systemic immunosuppressive drugs including systemic corticosteroids, ICS with doses > 800 μg/day budesonide (or another ICS of equivalent dose), long-acting β2 agonists, cromolyn sodium, nedocromil sodium, leukotriene receptor antagonists, theophylline, or omalizumab from screening through Study Day 150;
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 |
|---|---|---|
| MEDI528 50 mgMEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks | Biological | MEDI528 50 mg |
| PLACEBOPlacebo administered as a subcutaneous injection twice weekly for 4 weeks | Other | PLACEBO |
Primary outcome
Incidence of Adverse Events
Time frame: Days 0 - 150
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Incidence of Serious Adverse Events
Time frame: Days 0 - 150
Number of participants experiencing serious adverse events
17 secondary outcomes
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Time frame: Days 0, 28, 56, 119, and 150
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Mean Trough Concentration (Cmin)
Time frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150
Mean Trough Concentration at Last Measurable Time Point (Cmin_last)
Time frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150
Half-life (T1/2)
Time frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150
Accumulation Index
Time frame: Days 0 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21356110Parker JM, Oh CK, LaForce C, Miller SD, Pearlman DS, Le C, Robbie GJ, White WI, White B, Molfino NA; MEDI-528 Clinical Trials Group. Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma. BMC Pulm Med. 2011 Feb 28;11:14. doi: 10.1186/1471-2466-11-14.
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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.
Joseph Parker, M.D. study director
MedImmune LLC
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI528 50 mg in people with Asthma, run by MedImmune LLC at 12 sites in 2 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 11 inclusion and 24 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: stopped early, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. 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 Mar 2014). 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?
Incidence of Adverse Events (time frame: Days 0 - 150). 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 NCT00590720, 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 21 Mar 2014.