Clinical Study of Caffeine for Apnea of Prematurity

Apnea of Prematurity Clinical Trial

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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408173
• Other study ID #: NPC-11-1
• Status: Completed
• Phase: Phase 3
• First received: July 29, 2011
• Last updated: October 29, 2013
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2013
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 33 Weeks

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Apnea of Prematurity
• Premature Birth

Intervention

Drug:
• NPC-11 for intravenous or oral administration.
NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).

Locations

Country	Name	City	State
Japan	Tokyo Metropolitan Children's Medical Center	Fuchu	Tokyo
Japan	Osaka Medical Center and Research Institute for Maternal and Child Health	Izumi	Osaka
Japan	Fujita Health University Hospital	Kutsukake	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baseline)		1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day	No
Secondary	The change of frequency of apnea episode from baseline in each observation day		1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day	No
Secondary	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.	1 to 10 day	No
Secondary	The change of average duration time of apnea episode from baseline in each observation day		1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day	No
Secondary	The change of lowest oxygen saturation during apnea episodes from baseline in each observation day		1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day	No
Secondary	The proportion of less than 85% oxygen saturation during apnea episodes in each observation day		1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day	No