PrematurityPhase 2NCT01467076
Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
A Phase 2 study testing Aerosolized Normal Saline and Inhaled PGE1 in people with Prematurity and Respiratory Insufficiency, run by NICHD Neonatal Research Network at 11 sites in United States.
Trial summary
This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate the feasibility and safety of prolonged… Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Prematurity, Respiratory Insufficiency, Pulmonary Hypertension
- What is being tested?
- Aerosolized Normal Saline and Inhaled PGE1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2011to Jun 2012
- 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 Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age less than or equal to 34 weeks
- Postnatal age less than or equal to 7 days (168 hours).
- Assisted ventilation for hypoxemic respiratory failure.
- Diagnosis of NHRF including perinatal aspiration syndrome (meconium, blood, or amniotic fluid), suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic persistent pulmonary hypertension of the newborn (PPHN) or suspected pulmonary hypoplasia.
- Receiving INO for at least 1 hour and not >72 hours.
- Oxygenation Index (OI ) ≥ 15 on any 2 arterial blood gases 15 minutes to 12 hours apart while on INO.
- An indwelling arterial line is present
Who cannot join
- Any infant in whom a decision has been made not to provide full treatment (e.g. chromosomal anomalies, severe birth asphyxia).
- Known structural congenital heart disease except patent ductus arteriosus and atrial/ventricular level shunts.
- Congenital diaphragmatic hernia.
- Thrombocytopenia unresponsive to platelet transfusion.
- Enrollment in a conflicting and/or Investigational New Drug (IND) clinical trial.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
Duke University
Durham, North Carolina, 27710
University of Iowa
Iowa City, Iowa, 52242
University of California - Los Angeles
Los Angeles, California, 90025
Stanford University
Palo Alto, California, 94304
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
University of Rochester
Rochester, New York, 14642
About this study
Official title: Pilot Randomized Clinical Trial of Inhaled PGE1 in Neonates With Sub-Optimal Response to Inhaled Nitric Oxide
This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate the feasibility and safety of prolonged IPGE1 administration and determination of optimal dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale randomized controlled trial will be planned.
Read the detailed description
Hypoxemic respiratory failure in the newborn (NHRF) is usually associated with widespread vasoconstriction of the pulmonary microvasculature giving rise to intra- and extra-pulmonary shunts and profound hypoxemia. The goal of therapy is to decrease the regional pulmonary vascular resistance of ventilated lung areas thus decreasing intrapulmonary shunting and selectively reducing the pulmonary-artery pressure without causing systemic vasodilation. Intravenously administered vasodilators lack pulmonary selectivity leading to systemic side effects. Inhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of respiratory failure in the newborn. However, there is lack of sustained improvement in 30-46% of infants; moreover, INO requires specialized systems for administration, making the treatment expensive. Aerosolized prostaglandins I2 and E1 have been reported to be effective selective pulmonary vasodilators in animals and human adults. In addition, inhaled prostaglandin I2 (IPGI2) has also been reported to be effective in preterm and term newborns, and children with pulmonary hypertension. Although intravenous PGE1 is widely used in neonates, the use of the inhaled form has not been reported in newborns with pulmonary hypertension. Compared to PGI2, PGE1 has a shorter half-life, lower acidity constant (pKa) (6.3 versus 10.5), bronchodilator action, anti-proliferative and anti-inflammatory effects on the alveolar, interstitial and vascular spaces of the lung. Prostaglandin nebulization can be used without the sophisticated technical equipment needed for controlled NO inhalation and hence is less expensive. It has no known toxic metabolites or toxic effects. Prostaglandins and nitric oxide (NO) relax the vascular smooth muscles through two different second-messenger systems; therefore, in combination, INO and IPGE1 may have synergistic effect. The existing literature suggests that inhaled PGE1 is a potential effective vasodilator in the treatment of NHRF . We have reported the safety and feasibility of short-term administration of inhaled PGE1 in an un-blinded Phase I/II dose-escalation study. Four doses ranging from 25 to 300 ng/kg/min were tested for a maximum duration of 3 hours. We have also reported the stability of IPGE1, its emitted dose and aerosol particle size distribution (APSD) in a neonatal ventilator circuit. In addition we have demonstrated the safety of high dose IPGE1 (1200 ng/kg/min) over 24 hours in ventilated piglets. In the current protocol, we propose a pilot to evaluate the feasibility and safety of prolonged IPGE1 in NHRF. Two doses of IPGE1 (300 and 150 ng/kg/min) will be tested followed by weaning for a maximum duration of 72 hours to determine feasibility, safety, optimal dose and duration of therapy in 50 patients in ten NICHD NRN sites. An IND status has been approved by the FDA for this trial.
- Conditions
- Prematurity, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn
- Being tested
- Aerosolized Normal Saline, Inhaled PGE1
- Medical subject headings
- Premature Birth, Respiratory Insufficiency, Hypertension, Pulmonary, Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosolized Normal SalineDrug
Also called Normal Saline
Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 [150], IPGE1 [300], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. Placebo will be administered over a maximum duration of 72 hours.
Inhaled PGE1Drug
Also called Inhaled Prostaglandin E1
Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 [150], IPGE1 [300], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours to determine the optimal dose and duration of therapy.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled PGE1 (150 ng/kg/min) | Active comparator | 150 ng/kg/min Inhaled PGE1 Receives: Drug: Inhaled PGE1 |
| Aerosolized Normal Saline | Placebo comparator | Eligible infants will be randomly assigned to either IPGE1 [150ng/kg/min], IPGE1 [300ng/kg/min] or control group. Infants in the control group will receive the same volume of aerosolized saline and oxygen from the respirator. Receives: Drug: Aerosolized Normal Saline |
| Inhaled PGE1 (300 ng/kg/min) | Active comparator | 300 ng/kg/min of Inhaled PGE1 Receives: Drug: Inhaled PGE1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study
The primary outcome is the ability to recruit adequate number of infants (n=50) in a 9 month period without excessive (>20%) protocol violations.
Measured: From study start through 9 months after 75% of the participating sites are enrolling
Secondary outcomes (9)
Change in Partial Pressure of Oxygen in the Blood (PaO2)
Changes in PaO2 based on the arterial blood gases (ABG) measurements obtained after 60 minutes and ABG obtained 4 hours after start of study aerosol.
Measured: Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol.
Change in Oxygenation Index (OI)
Change in OI based on the arterial blood gases (ABG) measurements obtained at 60±15 minutes and ABG obtained 4±2 hours after start of study aerosol.
Measured: Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol.
Need for Inhaled Nitric Oxide (INO) 72 Hours After INO
Administration of INO continued after the Infant was on INO for 72 hours
Measured: Date of first administration of INO to date of final discontinuation of INO
Duration of iNO Therapy
Duration the infant is on INO from initial administration of INO to final discontinuation of INO.
Measured: From date of first administration of INO to date of final discontinuation of INO.
Death
Deaths prior to discharge home.
Measured: From birth through status (death, transfer, or discharge).
Need for Extracorporeal Membrane Oxygenation (ECMO)
ECMO provided at the institution for the infant after discontinuation of study aerosol.
Measured: From after discontinuation of study aerosol through status (death, transfer, or discharge).
Duration of Mechanical Ventilation
Duration the infant is on Mechanical Ventilation from birth through status (death, transfer or discharge)
Measured: From birth through status (death, transfer or discharge)
Number of Days of Supplemental Oxygen (O2) Used
Number of days from birth during which the FiO2 at some point was > 0.21.
Measured: From birth through status (death, transfer or discharge)
Length of Hospital Stay
Length of stay in hospital from birth to discharge home.
Measured: From birth to discharge home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionJun 2012
Why it stopped: The study was halted due to futility concerns based on the unmet benchmarks as specified in the pilot study protocol.
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 PrematurityStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Beena Sood, MD, Principal investigator, Wayne State UniversityMartin Keszler, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandC. Michael Cotten, MD, Principal investigator, Duke UniversityAbhik Das, PhD, Principal investigator, RTI InternationalKrisa P Van Meurs, MD, Principal investigator, Stanford UniversityNamasivayam Ambalavanan, MD, Principal investigator, University of Alabama at BirminghamJonathan M Klein, MD, Principal investigator, University of IowaRobin Ohls, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467076
- Sponsor's protocol ID
- NICHD-NRN-0046
- Other IDs
- U10HD040689, U10HD021385, U10HD027904, U10HD027880, U10HD034216, U10HD040492, U10HD053109, U10HD040461
- Status last verified
- Apr 2019
- First submitted
- 17 Oct 2011
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sood BG, Keszler M, Garg M, Klein JM, Ohls R, Ambalavanan N, Cotten CM, Malian M, Sanchez PJ, Lakshminrusimha S, Nelin LD, Van Meurs KP, Bara R, Saha S, Das A, Wallace D, Higgins RD, Shankaran S; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials. Trials. 2014 Dec 12;15:486. doi: 10.1186/1745-6215-15-486.
PubMed 25496504
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Clinical Trial of Inhaled PGE1 in Neonates With Sub-Optimal Response to Inhaled Nitric Oxide
- ClinicalTrials.gov ID
- NCT01467076
- Acronym / sponsor ID
- NICHD-NRN-0046
- Conditions
- Prematurity, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted due to futility concerns based on the unmet benchmarks as specified in the pilot study protocol.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Posted 30 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate the feasibility and safety of prolonged IPGE1 administration and determination of optimal dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale randomized controlled trial will be planned.
Detailed description
Hypoxemic respiratory failure in the newborn (NHRF) is usually associated with widespread vasoconstriction of the pulmonary microvasculature giving rise to intra- and extra-pulmonary shunts and profound hypoxemia. The goal of therapy is to decrease the regional pulmonary vascular resistance of ventilated lung areas thus decreasing intrapulmonary shunting and selectively reducing the pulmonary-artery pressure without causing systemic vasodilation. Intravenously administered vasodilators lack pulmonary selectivity leading to systemic side effects. Inhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of respiratory failure in the newborn. However, there is lack of sustained improvement in 30-46% of infants; moreover, INO requires specialized systems for administration, making the treatment expensive. Aerosolized prostaglandins I2 and E1 have been reported to be effective selective pulmonary vasodilators in animals and human adults. In addition, inhaled prostaglandin I2 (IPGI2) has also been reported to be effective in preterm and term newborns, and children with pulmonary hypertension. Although intravenous PGE1 is widely used in neonates, the use of the inhaled form has not been reported in newborns with pulmonary hypertension. Compared to PGI2, PGE1 has a shorter half-life, lower acidity constant (pKa) (6.3 versus 10.5), bronchodilator action, anti-proliferative and anti-inflammatory effects on the alveolar, interstitial and vascular spaces of the lung. Prostaglandin nebulization can be used without the sophisticated technical equipment needed for controlled NO inhalation and hence is less expensive. It has no known toxic metabolites or toxic effects. Prostaglandins and nitric oxide (NO) relax the vascular smooth muscles through two different second-messenger systems; therefore, in combination, INO and IPGE1 may have synergistic effect. The existing literature suggests that inhaled PGE1 is a potential effective vasodilator in the treatment of NHRF . We have reported the safety and feasibility of short-term administration of inhaled PGE1 in an un-blinded Phase I/II dose-escalation study. Four doses ranging from 25 to 300 ng/kg/min were tested for a maximum duration of 3 hours. We have also reported the stability of IPGE1, its emitted dose and aerosol particle size distribution (APSD) in a neonatal ventilator circuit. In addition we have demonstrated the safety of high dose IPGE1 (1200 ng/kg/min) over 24 hours in ventilated piglets. In the current protocol, we propose a pilot to evaluate the feasibility and safety of prolonged IPGE1 in NHRF. Two doses of IPGE1 (300 and 150 ng/kg/min) will be tested followed by weaning for a maximum duration of 72 hours to determine feasibility, safety, optimal dose and duration of therapy in 50 patients in ten NICHD NRN sites. An IND status has been approved by the FDA for this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inhaled PGE1 (150 ng/kg/min) | Active comparator | Drug: Inhaled PGE1150 ng/kg/min Inhaled PGE1 |
| Aerosolized Normal Saline | Placebo comparator | Drug: Aerosolized Normal SalineEligible infants will be randomly assigned to either IPGE1 [150ng/kg/min], IPGE1 [300ng/kg/min] or control group. Infants in the control group will receive the same volume of aerosolized saline and oxygen from the respirator. |
| Inhaled PGE1 (300 ng/kg/min) | Active comparator | Drug: Inhaled PGE1300 ng/kg/min of Inhaled PGE1 |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Gestational age less than or equal to 34 weeks
- Postnatal age less than or equal to 7 days (168 hours).
- Assisted ventilation for hypoxemic respiratory failure.
- Diagnosis of NHRF including perinatal aspiration syndrome (meconium, blood, or amniotic fluid), suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic persistent pulmonary hypertension of the newborn (PPHN) or suspected pulmonary hypoplasia.
- Receiving INO for at least 1 hour and not >72 hours.
Key exclusion criteria (5 listed)
- Any infant in whom a decision has been made not to provide full treatment (e.g. chromosomal anomalies, severe birth asphyxia).
- Known structural congenital heart disease except patent ductus arteriosus and atrial/ventricular level shunts.
- Congenital diaphragmatic hernia.
- Thrombocytopenia unresponsive to platelet transfusion.
- Enrollment in a conflicting and/or Investigational New Drug (IND) clinical trial.
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 |
|---|---|---|
| Aerosolized Normal SalineAlso: Normal SalineTwo initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 [150], IPGE1 [300], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. Placebo will be administered over a maximum duration of 72 hours. | Drug | Aerosolized Normal Saline |
| Inhaled PGE1Also: Inhaled Prostaglandin E1Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 [150], IPGE1 [300], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours to determine the optimal dose and duration of therapy. | Drug | Inhaled PGE1 (150 ng/kg/min), Inhaled PGE1 (300 ng/kg/min) |
Primary outcome
Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study
Time frame: From study start through 9 months after 75% of the participating sites are enrolling
The primary outcome is the ability to recruit adequate number of infants (n=50) in a 9 month period without excessive (>20%) protocol violations.
9 secondary outcomes
Change in Partial Pressure of Oxygen in the Blood (PaO2)
Time frame: Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol.
Change in Oxygenation Index (OI)
Time frame: Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol.
Need for Inhaled Nitric Oxide (INO) 72 Hours After INO
Time frame: Date of first administration of INO to date of final discontinuation of INO
Duration of iNO Therapy
Time frame: From date of first administration of INO to date of final discontinuation of INO.
Death
Time frame: From birth through status (death, transfer, or discharge).
Need for Extracorporeal Membrane Oxygenation (ECMO)
Time frame: From after discontinuation of study aerosol through status (death, transfer, or discharge).
Duration of Mechanical Ventilation
Time frame: From birth through status (death, transfer or discharge)
Number of Days of Supplemental Oxygen (O2) Used
Time frame: From birth through status (death, transfer or discharge)
Length of Hospital Stay
Time frame: From birth to discharge home
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25496504Sood BG, Keszler M, Garg M, Klein JM, Ohls R, Ambalavanan N, Cotten CM, Malian M, Sanchez PJ, Lakshminrusimha S, Nelin LD, Van Meurs KP, Bara R, Saha S, Das A, Wallace D, Higgins RD, Shankaran S; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials. Trials. 2014 Dec 12;15:486. doi: 10.1186/1745-6215-15-486.
- Neonatal Research NetworkLink 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.
Beena Sood, MD principal investigator
Wayne State University
Martin Keszler, MD principal investigator
Brown University, Women & Infants Hospital of Rhode Island
C. Michael Cotten, MD principal investigator
Duke University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerosolized Normal Saline and Inhaled PGE1 in people with Prematurity and Respiratory Insufficiency, run by NICHD Neonatal Research Network at 11 sites in United States.
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 7 inclusion and 5 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 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 30 Dec 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?
Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study (time frame: From study start through 9 months after 75% of the participating sites are enrolling). 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 NCT01467076, 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 24 Apr 2019.