Clinical Study of Caffeine for Apnea of Prematurity
This study has been completed.
Information provided by (Responsible Party):
First received: July 29, 2011
Last updated: October 29, 2013
Last verified: October 2013
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.
Apnea of Prematurity
Drug: NPC-11 for intravenous or oral administration.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase III Clinical Study of NPC-11 in the Treatment of Apnea of Prematurity. - Investigation of Safety, Efficacy and Pharmacokinetics of Caffeine Citrate -
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Time to event：Days until next events occurred [ Time Frame: 1 to 10 day ] [ Designated as safety issue: No ]
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.
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
- 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.
Drug: NPC-11 for intravenous or oral administration.
NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).
Other Name: caffeine citrate
|Ages Eligible for Study:
||28 Weeks to 33 Weeks (Child)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408173
|Fujita Health University Hospital
|Kutsukake, Aichi, Japan |
|Osaka Medical Center and Research Institute for Maternal and Child Health
|Izumi, Osaka, Japan |
|Tokyo Metropolitan Children's Medical Center
|Fuchu, Tokyo, Japan |
||Susumu Itoh, MD, PhD
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 29, 2011
||October 29, 2013
||Japan: Pharmaceuticals and Medical Devices Agency
Keywords provided by Nobelpharma:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Calcium Chelating Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Physiological Effects of Drugs
Purinergic P1 Receptor Antagonists