Apnea of PrematurityPhase 3NCT01408173
Clinical Study of Caffeine for Apnea of Prematurity
A Phase 3 study testing NPC-11 for intravenous or oral administration. in people with Apnea of Prematurity, run by Nobelpharma at 3 sites in Japan.
Trial summary
The aim of the present Phase III study is to evaluate the safety, efficacy and pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan. Read more about this study
- Who is it for?
- Ages 28 to 33 weeks
- Conditions the study is for
- Apnea of Prematurity
- What is being tested?
- NPC-11 for intravenous or oral administration.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesJapan
- Study dates
- Aug 2011to Oct 2012
- 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 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Postconceptional age between 28 weeks and 33 weeks, and over 24 hours after birth.
- At least 6 episodes of apnea (>20 seconds in duration) in 24 hours.
- Signed written informed consent from parent(s) or legal guardian(s).
Who cannot join
- Apnea due to: hypoxic-ischemic encephalopathy, meningitis, seizures, Grade III or IV intracranial hemorrhage, CNS depression from drugs administered to the mother during delivery, periventricular leukomalacia, pneumonia which does not improve even if it treats, hemoglobin< 10 g/dL, sepsis, shock which does not improve even if it treats, blood pH<7.2 on 2 consecutive determinations in spite of correction, serum calcium concentration <7.0 mg/dL which does not improve even if it treats, serum glucose concentration <4.0 mg/dL which does not improve even if it treats, congestive heart failure, symptomatic patent ductus arteriosus, rectal temperature>38.5 °C on 2 consecutive readings, rectal temperature< 35 °C on 2 consecutive readings, obstructive apnea.
- Blood urea nitrogen >20 mg/dL, serum creatinine >1.5 mg/dL.
- Serum AST or ALT >3 times the upper limit of normal.
- Requirement of mechanically-assisted ventilation ( containing nasal CPAP, nasal DPAP).
- Previous treatment with methylxanthines within 7 days prior to study enrollment.
- Previous treatment with H2 antagonists (i.e., cimetidine or ranitidine) within 7 days prior to study enrollment.
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- Receiving or experiencing the effects of CNS-active medication at the time of enrollment.
- Participant of other clinical trial within 6 months.
- Inappropriate to enter this clinical trial judged by the investigator in charge.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka
Fujita Health University Hospital
Kutsukake, Aichi-ken
About this study
Official title: A Phase III Clinical Study of NPC-11 in the Treatment of Apnea of Prematurity. - Investigation of Safety, Efficacy and Pharmacokinetics of Caffeine Citrate -
The aim of the present Phase III study is to evaluate the safety, efficacy and pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.
- Conditions
- Apnea of Prematurity
- Being tested
- NPC-11 for intravenous or oral administration.
- Keywords
- caffeine, apnea, prematurity
- Medical subject headings
- Apnea, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-11 for intravenous or oral administration.Drug
Also called caffeine citrate
NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).
| Study group | Role | What they receive |
|---|---|---|
| NPC-11 | Experimental | * Loading Dose (Day 1): Caffeine citrate 20 mg/kg body weight will be administered intravenously using a syringe infusion pump over 30 minutes.
* Maintenance Dose (Day 2～Day 10): After an interval 24 hours, caffeine citrate 5 mg/kg body weight will be administered intravenously (over 10 minutes) or orally if the patients will be able to receive oral administration once a day. The maintenance dose can be increased to a maximum 10 mg/kg caffeine citrate once a day if apnea persists. Receives: Drug: NPC-11 for intravenous or oral administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baseline)
Measured: 1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day
Secondary outcomes (5)
The change of frequency of apnea episode from baseline in each observation day
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
Time to event：Days until next events occurred
Time to event：Days until next events occurred.
The definition of events are, Not at least 50% reduction of apnea episode Not improving the frequency of episode from baseline Needs mechanical/bag valve mask ventilation.
Measured: 1 to 10 day
The change of average duration time of apnea episode from baseline in each observation day
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
The change of lowest oxygen saturation during apnea episodes from baseline in each observation day
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
The proportion of less than 85% oxygen saturation during apnea episodes in each observation day
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea of 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susumu Itoh, MD, PhD, Principal investigator, Kagawa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408173
- Sponsor's protocol ID
- NPC-11-1
- Status last verified
- Oct 2013
- First submitted
- 29 Jul 2011
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study of NPC-11 in the Treatment of Apnea of Prematurity. - Investigation of Safety, Efficacy and Pharmacokinetics of Caffeine Citrate -
- ClinicalTrials.gov ID
- NCT01408173
- Acronym / sponsor ID
- NPC-11-1
- Conditions
- Apnea of Prematurity
- Keywords
- caffeine, apnea, prematurity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Aug 2011 (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 aim of the present Phase III study is to evaluate the safety, efficacy and pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPC-11 | Experimental | Drug: NPC-11 for intravenous or oral administration.* Loading Dose (Day 1): Caffeine citrate 20 mg/kg body weight will be administered intravenously using a syringe infusion pump over 30 minutes. * Maintenance Dose (Day 2～Day 10): After an interval 24 hours, caffeine citrate 5 mg/kg body weight will be administered intravenously (over 10 minutes) or orally if the patients will be able to receive oral administration once a day. The maintenance dose can be increased to a maximum 10 mg/kg caffeine citrate once a day if apnea persists. |
Who may qualify
- Ages
- 28 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Postconceptional age between 28 weeks and 33 weeks, and over 24 hours after birth.
- At least 6 episodes of apnea (>20 seconds in duration) in 24 hours.
- Signed written informed consent from parent(s) or legal guardian(s).
Key exclusion criteria (9 listed)
- Apnea due to: hypoxic-ischemic encephalopathy, meningitis, seizures, Grade III or IV intracranial hemorrhage, CNS depression from drugs administered to the mother during delivery, periventricular leukomalacia, pneumonia which does not improve even if it treats, hemoglobin< 10 g/dL, sepsis, shock which does not improve even if it treats, blood pH<7.2 on 2 consecutive determinations in spite of correction, serum calcium concentration <7.0 mg/dL which does not improve even if it treats, serum glucose concentration <4.0 mg/dL which does not improve even if it treats, congestive heart failure, symptomatic patent ductus arteriosus, rectal temperature>38.5 °C on 2 consecutive readings, rectal temperature< 35 °C on 2 consecutive readings, obstructive apnea.
- Blood urea nitrogen >20 mg/dL, serum creatinine >1.5 mg/dL.
- Serum AST or ALT >3 times the upper limit of normal.
- Requirement of mechanically-assisted ventilation ( containing nasal CPAP, nasal DPAP).
- Previous treatment with methylxanthines within 7 days prior to study enrollment.
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 |
|---|---|---|
| NPC-11 for intravenous or oral administration.Also: caffeine citrateNPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine). | Drug | NPC-11 |
Primary outcome
Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baseline)
Time frame: 1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day
5 secondary outcomes
The change of frequency of apnea episode from baseline in each observation day
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
Time to event：Days until next events occurred
Time frame: 1 to 10 day
The change of average duration time of apnea episode from baseline in each observation day
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
The change of lowest oxygen saturation during apnea episodes from baseline in each observation day
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
The proportion of less than 85% oxygen saturation during apnea episodes in each observation day
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
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 30 Oct 2013.
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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.
Susumu Itoh, MD, PhD principal investigator
Kagawa University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPC-11 for intravenous or oral administration. in people with Apnea of Prematurity, run by Nobelpharma at 3 sites in Japan.
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 3 inclusion and 9 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 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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. 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?
Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baseline) (time frame: 1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day). 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 30 Oct 2013.