Patent Ductus ArteriosusPhase 3NCT00440804
Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA
A Phase 3 study testing ibuprofen l-lysine iv solution (NeoProfen (R) ) in people with Patent Ductus Arteriosus, run by Farmacon.
Trial summary
The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus. Read more about this study
- Who is it for?
- Ages 28 to 34 weeks
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- ibuprofen l-lysine iv solution (NeoProfen (R) )
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 2002to Aug 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 28 to 34 weeks
- All sexes
- Child
Who may be able to join
- Premature newborn infant of either gender with a birth weight of 500 to 1000 grams, appropriate for gestational age;
- Non-symptomatic PDA with evidence of ductal shunting documented by an echocardiogram (ECHO);
- Less than 72 hours of age at the time of randomization;
- If infant is one of a multiple birth, he/she is one of the two (2) oldest infants who meet the eligibility criteria;
- Consent form signed by parent.
Who cannot join
- Either major congenital malformations and/or chromosomal anomalies;
- Proven, severe congenital bacterial infection;
- Maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure < 72 hours prior to delivery;
- Treatment with pharmacological replacement steroid therapy at anytime since birth;
- Unremitting shock requiring very high doses of vasopressors (i.e. inability to maintain mean arterial blood pressure appropriate for gestational age ± 2 SD using volume and maximal vasopressor therapy as defined by the individual institution);
- Renal failure or oliguria defined as urine flow rate < 0.5 mL/kg/hr in the 8 hours prior to randomization (Anuria is acceptable if infant is in first 24 hours of life);
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- Platelet count < 75,000/mm 3;
- Clinical bleeding tendency (i.e. oozing from puncture sites);
- Expected survival less than 48 hours in the opinion of the attending neonatologist;
- Participation in other clinical intervention trials. Exceptions may be made if approved by Medical Director or designee, RPD Pharmaceutical Department;
- Symptomatic PDA as documented by 3 of the following 5 criteria
- Bounding pulse
- Hyperdynamic precordium
- Pulmonary edema
- Increased cardiac silhouette
- Systolic murmur Or, in view of the neonatologist is deemed to have a hemodynamically significant ductus.
- Exposure to NSAIDs at any time since birth.
About this study
Official title: Randomized, Double-Blind Study of Ibuprofen L-Lysine Intravenous Solution in Premature Infants for the Early Treatment of Patent Ductus Arteriosus
The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.
Read the detailed description
The ductus arteriosus remains patent in about 40% to 80% of very low birth weight infants. Early treatment by intravenous ibuprofen L-lysine (IV ibuprofen) has been suggested in preliminary studies to close the ductus and shorten hospital stay. This study aims to determine the effect of early treatment with IV ibuprofen given to the very low birth weight infant with a non-symptomatic patent ductus arteriosus (PDA) at less than 72 hours of life to accelerate and maintain ductal closure, thereby reducing the need for rescue therapy.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- ibuprofen l-lysine iv solution (NeoProfen (R) )
- Keywords
- patent ductus arterious
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofen l-lysine iv solution (NeoProfen (R) )Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measures (Efficacy)
Secondary outcomes (17)
Gastrointestinal function
Renal function
Hematology
Liver enzyme tests
Serum bilirubin
Respiratory function
Intraventricular hemorrhage
Pulmonary hemorrhage
Pulmonary hypertension
Exploratory outcomes:
Ibuprofen concentrations
Prostanoid concentrations
CYP2C9 Genotyping
Follow-up Outcomes
Retinopathy of Prematurity
Bronchopulmonary dysplsia
Periventricular leukomalacia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startDec 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies 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
Sponsor and investigators
- Lead sponsor
- Farmacon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacob V Aranda, MD, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440804
- Sponsor's protocol ID
- FCR-00-01/CB88
- Status last verified
- Feb 2007
- First submitted
- 23 Feb 2007
- Last updated
- 27 Feb 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Study of Ibuprofen L-Lysine Intravenous Solution in Premature Infants for the Early Treatment of Patent Ductus Arteriosus
- ClinicalTrials.gov ID
- NCT00440804
- Acronym / sponsor ID
- FCR-00-01/CB88
- Conditions
- Patent Ductus Arteriosus
- Keywords
- patent ductus arterious
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- FarmaconIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Aug 2005
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
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 determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.
Detailed description
The ductus arteriosus remains patent in about 40% to 80% of very low birth weight infants. Early treatment by intravenous ibuprofen L-lysine (IV ibuprofen) has been suggested in preliminary studies to close the ductus and shorten hospital stay. This study aims to determine the effect of early treatment with IV ibuprofen given to the very low birth weight infant with a non-symptomatic patent ductus arteriosus (PDA) at less than 72 hours of life to accelerate and maintain ductal closure, thereby reducing the need for rescue therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (5 listed)
- Premature newborn infant of either gender with a birth weight of 500 to 1000 grams, appropriate for gestational age;
- Non-symptomatic PDA with evidence of ductal shunting documented by an echocardiogram (ECHO);
- Less than 72 hours of age at the time of randomization;
- If infant is one of a multiple birth, he/she is one of the two (2) oldest infants who meet the eligibility criteria;
- Consent form signed by parent.
Key exclusion criteria (17 listed)
- Either major congenital malformations and/or chromosomal anomalies;
- Proven, severe congenital bacterial infection;
- Maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure < 72 hours prior to delivery;
- Treatment with pharmacological replacement steroid therapy at anytime since birth;
- Unremitting shock requiring very high doses of vasopressors (i.e. inability to maintain mean arterial blood pressure appropriate for gestational age ± 2 SD using volume and maximal vasopressor therapy as defined by the individual institution);
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 |
|---|---|---|
| ibuprofen l-lysine iv solution (NeoProfen (R) ) | Drug | – |
Primary outcome
Primary Outcome Measures (Efficacy)
17 secondary outcomes
Gastrointestinal function
Renal function
Hematology
Liver enzyme tests
Serum bilirubin
Respiratory function
Intraventricular hemorrhage
Pulmonary hemorrhage
Pulmonary hypertension
Exploratory outcomes:
Ibuprofen concentrations
Prostanoid concentrations
CYP2C9 Genotyping
Follow-up Outcomes
Retinopathy of Prematurity
Bronchopulmonary dysplsia
Periventricular leukomalacia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
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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.
Jacob V Aranda, MD, PhD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ibuprofen l-lysine iv solution (NeoProfen (R) ) in people with Patent Ductus Arteriosus, run by Farmacon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 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 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Outcome Measures (Efficacy). 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 27 Feb 2007.