Trials / Completed
CompletedNCT01408173
Clinical Study of Caffeine for Apnea of Prematurity
A Phase III Clinical Study of NPC-11 in the Treatment of Apnea of Prematurity. - Investigation of Safety, Efficacy and Pharmacokinetics of Caffeine Citrate -
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Nobelpharma · Industry
- Sex
- All
- Age
- 28 Weeks – 33 Weeks
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NPC-11 for intravenous or oral administration. | NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine). |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2012-10-01
- Completion
- 2012-10-01
- First posted
- 2011-08-03
- Last updated
- 2013-10-30
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01408173. Inclusion in this directory is not an endorsement.