Angiotensin Converting Enzyme Inhibitor Induced AngioedemaPhase 3NCT01919801
Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema
A Phase 3 study testing Icatibant in people with Angiotensin Converting Enzyme Inhibitor Induced Angioedema, run by Shire at 55 sites in 4 countries.
Trial summary
This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiotensin Converting Enzyme Inhibitor Induced Angioedema
- What is being tested?
- Icatibant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 55 sitesin 4 countries
- Study dates
- 2 Dec 2013to 22 Aug 2015
- 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
- Male or female, 18 years of age or older.
- Patient is currently being treated with an ACE inhibitor.
- Patient presenting with an ACE inhibitor-induced angioedema attack of the head and/or neck region within 12 hours of onset (must be sufficiently less than 12 hours to allow study drug to be given with 12 hours of attack onset).
- Angioedema must be considered at least moderate in severity for at least one of the four angioedema-associated airway symptoms (difficulty breathing, difficulty swallowing, voice changes, tongue swelling).
- Patient must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient.
- Females must have a negative urine pregnancy test prior to administration of the study medication, with the exception of those females who have had a total hysterectomy or bilateral oophorectomy, or who are 2 years post-menopausal.
Who cannot join
- Patient has a diagnosis of angioedema of other etiology (eg, hereditary or acquired angioedema, allergic angioedema [eg, food, insect bite or sting, evident clinical response to antihistamines and/or corticosteroids], anaphylaxis, trauma, abscess or infection or associated disease, local inflammation, local tumor, post-operative or post-radiogenic edema, salivary gland disorders, other [non-ACE inhibitor] drug-induced angioedema).
- Patients with a family history of recurrent angioedema.
- Patients who have had a previous episode(s) of angioedema while not on ACE inhibitor therapy.
- Patients with acute urticaria (itchy, erythematous wheals).
- Patients who have an intervention to support the airway (eg, intubation, tracheotomy, cricothyrotomy) due to the current attack of angioedema.
- Patient has any of the following vascular conditions that, in the judgment of the investigator, would be a contraindication to participation in the study.
Show all 16Show fewer
- Unstable angina pectoris or acute myocardial ischemia
- Hypertensive urgency or emergency (diastolic blood pressure [DBP] >120 mm Hg or systolic blood pressure [SBP] >180 mm Hg)
- Within 1 month of a stroke or transient ischemic attack
- New York Heart Association (NYHA) heart failure class IV
- Patient has a serious or acute condition or illness that, in the judgment of the investigator, would interfere with evaluating the safety and/or efficacy assessments of the study (eg, a condition or illness requiring hemodialysis).
- Patient is pregnant or breast feeding.
- Patient has participated in another investigational study in the past 30 days.
- Patient is unable to understand the nature, scope, and possible consequences of the protocol, or is unlikely or unable to comply with the protocol assessments, or is unlikely to complete the study for any reason.
- Patients who are not suitable for the study in the opinion of the investigator.
- Patient has experienced hypersensitivity to the active substance of the investigational product or to any of its excipients.
Trial locations and contacts
55 sites in 4 countries.
55 sites in 4 countries
United States43 sites
University of New Mexico
Albuquerque, New Mexico, 87106
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Kings County Hospital Center
Brooklyn, New York, 11203
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Summit Health
Chambersburg, Pennsylvania, 17201
University of Virginia
Charlottesville, Virginia, 22903
Federal Health Care Center
Chicago, Illinois, 60064-3048
Cook County Hospital
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of South Carolina School of Medicine
Columbia, South Carolina, 29203
Baylor University Medical Center
Dallas, Texas, 75246
Detroit Receiving Hospital and University Health Center
Detroit, Michigan, 48201
Sinai Grace Hospital
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
John Peter Smith Hospital
Fort Worth, Texas, 76104
Ohio State University Hospital - East
Gahanna, Ohio, 43230
UF Health Shands Hospital
Gainesville, Florida, 32610
University of Texas Medical Branch
Galveston, Texas, 77555-0561
East Carolina University
Greenville, North Carolina, 27835
Baylor College of Medicine
Houston, Texas, 77030
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University of California San Diego Medical Center
La Jolla, California, 92037
University of California San Diego
La Jolla, California, 92093
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Ochsner Medical Center
New Orleans, Louisiana, 70121
Weill Medical College of Cornell University
New York, New York, 10021
Orlando Health
Orlando, Florida, 32806
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15143
Rhode Island Hospital
Providence, Rhode Island, 02903
William Beaumont Hospital
Royal Oak, Michigan, 48073
Baystate Medical Center
Springfield, Massachusetts, 01199
Barnes Jewish Hospital
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63141
Tampa General Hospital
Tampa, Florida, 33606
William Beaumont Hospital
Troy, Michigan, 48085
Inspira Health Network
Vineland, New Jersey, 08360
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United Kingdom5 sites
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE
Royal Devon and Exeter Hospital NHS Trust
Exeter, EX2 5DW
University Hospital Aintree
Liverpool, L9 7AL
Manchester Royal Infirmary
Manchester, M13 9WL
Queen's Medical Centre
Nottingham, NG7 2UH
Israel4 sites
Soroka University Medical Center
Beersheba, 84101
Bnai Zion Medical Center
Haifa, 31048
Ziv Medical Center
Safed, 13100
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Canada3 sites
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
About this study
Official title: Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating the Safety & Efficacy of Icatibant as a Treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults
This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults.
Read the detailed description
Angiotensin-converting enzyme inhibitors (ACE-Is) are the class of medications prescribed most frequently for the treatment of hypertension. They are also used post myocardial infarction as well as in patients with heart failure, diabetes mellitus, and chronic kidney disease. Approximately 35 to 40 million patients are on ACE-Is worldwide.
Study HGT-FIR-096 is a multicenter, Phase III, randomized, double-blind, two-armed, placebo-controlled trial. The study population will consist of 118 adult patients, 18 years of age or older, who present with an acute ACE-I-induced angioedema attack. The primary aim of the study is to demonstrate that icatibant is significantly more effective than placebo in resolving attacks of angioedema caused by ACE-I based on the Time to Meeting Discharge Criteria (TMDC). Safety and tolerability, as well as the pharmacokinetics (PK), of icatibant will also be evaluated. Eligible patients will be randomized at a 1:1 ratio to receive a single sub-cutaneous injection of either 30 mg icatibant or placebo.
- Being tested
- Icatibant, Placebo
- Keywords
- icatibant, Firazyr, ACE-I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcatibantDrug
Also called Firazyr
Single dose of 30 mg icatibant administered within 12 hours of the onset of an acute attack of ACE-I-induced angioedema
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Icatibant | Experimental | Icatibant at a dose of 30 mg will be administered as a single subcutaneous injection Receives: Drug: Icatibant |
| Placebo | Placebo comparator | Placebo will be administered as a single subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Meeting Discharge Criteria (TMDC)
TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.
Measured: Day 0 up to Day 5
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
Measured: From start of study drug administration (Day 0) up to follow-up (Day 5)
Number of Participants With Treatment Emergent Injection Site Reaction
Injection site reaction included erythema, swelling, cutaneous pain, burning sensation, itching and warm sensation
Measured: Day 0 to Day 5
Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination
During laboratory evaluation, serum chemistry and hematology blood tests, and urinalysis were performed. Vital signs parameters included evaluation of pulse rate and systolic and diastolic blood pressure. Standard 12-lead ECGs were performed and ECG recordings were read locally at the study site by a cardiologist. Physical examination was performed with examination of major body systems per routine clinical practice.
Measured: Day 0 to Day 5
Secondary outcomes (5)
Time to Onset of Symptom Relief (TOSR)
TOSR was calculated for the individual symptoms with pre-treatment scores of 2 (moderate) or more improved by at least 1 severity grade and the individual symptoms with pretreatment scores of 0 or 1 (absent or mild) were scored again at 0 or 1 and all the subsequent assessments continued to satisfy this condition. Time-to-event data were summarized using Kaplan-Meier estimates.
Measured: Day 0 up to Day 5
Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema
Airway Intervention included intubation, tracheotomy, cricothyrotomy.
Measured: Day 0 up to Day 5
Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)
Number of participants with and without an occurrence of admission to the hospital (inpatient) or ICU post-treatment due to the ACE-I-induced angioedema attack were described.
Measured: Day 0 up to Day 5
Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration
Number of participants with the use of conventional medications (corticosteroids, antihistamines, epinephrine) for the treatment of symptoms of the ACE-I- induced angioedema attack following study drug administration were presented.
Measured: Day 0 up to Day 5
Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points
TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.
Measured: 4, 6, and 8 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study start2 Dec 2013
- Primary completion22 Aug 2015
- Study completion22 Aug 2015
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 Angiotensin Converting Enzyme Inhibitor Induced AngioedemaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919801
- Sponsor's protocol ID
- HGT-FIR-096
- Other IDs
- 2014-001213-12, 2014
- Status last verified
- May 2021
- First submitted
- 25 Jul 2013
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sinert R, Levy P, Bernstein JA, Body R, Sivilotti MLA, Moellman J, Schranz J, Baptista J, Kimura A, Nothaft W; CAMEO study group. Randomized Trial of Icatibant for Angiotensin-Converting Enzyme Inhibitor-Induced Upper Airway Angioedema. J Allergy Clin Immunol Pract. 2017 Sep-Oct;5(5):1402-1409.e3. doi: 10.1016/j.jaip.2017.03.003. Epub 2017 May 25.
PubMed 28552382
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating the Safety & Efficacy of Icatibant as a Treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults
- ClinicalTrials.gov ID
- NCT01919801
- Acronym / sponsor ID
- HGT-FIR-096
- Keywords
- icatibant, Firazyr, ACE-I
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 2 Dec 2013 (actual)
- Primary completion
- 22 Aug 2015 (actual)
- Study completion
- 22 Aug 2015 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Posted 10 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults.
Detailed description
Angiotensin-converting enzyme inhibitors (ACE-Is) are the class of medications prescribed most frequently for the treatment of hypertension. They are also used post myocardial infarction as well as in patients with heart failure, diabetes mellitus, and chronic kidney disease. Approximately 35 to 40 million patients are on ACE-Is worldwide.
Study HGT-FIR-096 is a multicenter, Phase III, randomized, double-blind, two-armed, placebo-controlled trial. The study population will consist of 118 adult patients, 18 years of age or older, who present with an acute ACE-I-induced angioedema attack. The primary aim of the study is to demonstrate that icatibant is significantly more effective than placebo in resolving attacks of angioedema caused by ACE-I based on the Time to Meeting Discharge Criteria (TMDC). Safety and tolerability, as well as the pharmacokinetics (PK), of icatibant will also be evaluated. Eligible patients will be randomized at a 1:1 ratio to receive a single sub-cutaneous injection of either 30 mg icatibant or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icatibant | Experimental | Drug: IcatibantIcatibant at a dose of 30 mg will be administered as a single subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered as a single subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18 years of age or older.
- Patient is currently being treated with an ACE inhibitor.
- Patient presenting with an ACE inhibitor-induced angioedema attack of the head and/or neck region within 12 hours of onset (must be sufficiently less than 12 hours to allow study drug to be given with 12 hours of attack onset).
- Angioedema must be considered at least moderate in severity for at least one of the four angioedema-associated airway symptoms (difficulty breathing, difficulty swallowing, voice changes, tongue swelling).
- Patient must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient.
Key exclusion criteria (16 listed)
- Patient has a diagnosis of angioedema of other etiology (eg, hereditary or acquired angioedema, allergic angioedema [eg, food, insect bite or sting, evident clinical response to antihistamines and/or corticosteroids], anaphylaxis, trauma, abscess or infection or associated disease, local inflammation, local tumor, post-operative or post-radiogenic edema, salivary gland disorders, other [non-ACE inhibitor] drug-induced angioedema).
- Patients with a family history of recurrent angioedema.
- Patients who have had a previous episode(s) of angioedema while not on ACE inhibitor therapy.
- Patients with acute urticaria (itchy, erythematous wheals).
- Patients who have an intervention to support the airway (eg, intubation, tracheotomy, cricothyrotomy) due to the current attack of angioedema.
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 |
|---|---|---|
| IcatibantAlso: FirazyrSingle dose of 30 mg icatibant administered within 12 hours of the onset of an acute attack of ACE-I-induced angioedema | Drug | Icatibant |
| Placebo | Drug | Placebo |
Primary outcome
Time to Meeting Discharge Criteria (TMDC)
Time frame: Day 0 up to Day 5
TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From start of study drug administration (Day 0) up to follow-up (Day 5)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
Number of Participants With Treatment Emergent Injection Site Reaction
Time frame: Day 0 to Day 5
Injection site reaction included erythema, swelling, cutaneous pain, burning sensation, itching and warm sensation
Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination
Time frame: Day 0 to Day 5
During laboratory evaluation, serum chemistry and hematology blood tests, and urinalysis were performed. Vital signs parameters included evaluation of pulse rate and systolic and diastolic blood pressure. Standard 12-lead ECGs were performed and ECG recordings were read locally at the study site by a cardiologist. Physical examination was performed with examination of major body systems per routine clinical practice.
5 secondary outcomes
Time to Onset of Symptom Relief (TOSR)
Time frame: Day 0 up to Day 5
Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema
Time frame: Day 0 up to Day 5
Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)
Time frame: Day 0 up to Day 5
Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration
Time frame: Day 0 up to Day 5
Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points
Time frame: 4, 6, and 8 hours post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28552382Sinert R, Levy P, Bernstein JA, Body R, Sivilotti MLA, Moellman J, Schranz J, Baptista J, Kimura A, Nothaft W; CAMEO study group. Randomized Trial of Icatibant for Angiotensin-Converting Enzyme Inhibitor-Induced Upper Airway Angioedema. J Allergy Clin Immunol Pract. 2017 Sep-Oct;5(5):1402-1409.e3. doi: 10.1016/j.jaip.2017.03.003. Epub 2017 May 25.
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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.
Study Director study director
Takeda
55 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Icatibant in people with Angiotensin Converting Enzyme Inhibitor Induced Angioedema, run by Shire at 55 sites in 4 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 6 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 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, United Kingdom, Israel, 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 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 10 Oct 2016). 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?
Time to Meeting Discharge Criteria (TMDC) (time frame: Day 0 up to Day 5). The study lists 4 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 NCT01919801, 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 8 Jun 2021.