Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174928
Status:
COMPLETED
Last Update Posted:
2010-07-22
First Post:
2005-09-09
Brief Title:
A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 1 Single- and Repeated-Dose Randomized Open-Label Multi-center Study to Evaluate the Pharmacokinetics Pharmacodynamics and Safety of Lansoprazole in Neonates With Clinically-Evident Gastroesophageal Reflux Disease
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to understand how quickly lansoprazole once daily QD improves feeding in premature babies or babies less than 28 days of age
Detailed Description:
A Phase 1 multi-center pharmacokineticpharmacodynamic and safety study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansoprazole pediatric suspension 10 mgkgday orally or lansoprazole pediatric suspension 5 mgkgday orally On dosing Days 1 and 5 blood samples will be obtained for drug assay All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring provided it is clinically indicated at the discretion of the investigator Intragastric pH monitoring up to 24 hours will be performed at baseline on dosing Day 1 or Day 2 and on dosing Day 5 or Day 6 Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator Subjects will be evaluated for safety including a follow-up visit on post-dosing Day 14
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1113-9957 | REGISTRY | WHO | None |