A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00174928

Purpose

The study is being conducted to understand how quickly the study drug works to improve feeding and to study the safety of the drug in premature babies or babies less than 28 days of age.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: Lansoprazole	Phase I

MedlinePlus related topics: GERD

Drug Information available for: Lansoprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
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.

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Pharmacokinetic analysis [ Time Frame: Day 1 and 5 ] [ Designated as safety issue: No ]
Mean intragastric 24 hour pH (subset of six subjects) [ Time Frame: Day -1, Day 1 and Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GERD symptom analysis [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	May 2005
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lansoprazole Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 Days.
2: Experimental	Drug: Lansoprazole Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 Days.

Detailed Description:

A Phase 1, multi-center, pharmacokinetic/pharmacodynamic 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 1.0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day 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.

Eligibility

Ages Eligible for Study:	up to 28 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Neonates in the Neonatal Intensive Care or Special Care Nursery who have been fed orally or by feeding tube.
Term or post-term infants with a body weight of >800 gms.
Pre-term infants with a corrected age of less than 44 weeks.
Clinically-evident GERD (feeding intolerance, regurgitation, wheezing or stridor with feedings)
At least 7 days post-surgery without anticipated need for surgery during study
No significant laboratory abnormalities

Exclusion Criteria:

Unstable, clinically significant disease or abnormality
Congenital anomaly of the upper gastrointestinal tract
Clinical evidence of acute sepsis
Cystic fibrosis
Medical condition requiring subject to not be fed by mouth/gastric tube

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174928

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Trial results can be found on this link: This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls, refer to this link: This link exits the ClinicalTrials.gov site

For the Prevacid Package Insert, refer to this link: This link exits the ClinicalTrials.gov site

Publications of Results:

Springer M, Atkinson S, North J, Raanan M. Safety and pharmacodynamics of lansoprazole in patients with gastroesophageal reflux disease aged <1 year. Paediatr Drugs. 2008;10(4):255-63.

Zhang W, Kukulka M, Witt G, Sutkowski-Markmann D, North J, Atkinson S. Age-dependent pharmacokinetics of lansoprazole in neonates and infants. Paediatr Drugs. 2008;10(4):265-74.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences )
Study ID Numbers:	C03-042
Study First Received:	September 9, 2005
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00174928
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health

Keywords provided by Takeda Global Research & Development Center, Inc.:

Pediatric GERD
Pediatric Gastroesophageal Reflux Disease
Neonates
lansoprazole

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Lansoprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009