A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Infants With Clinically-Evident Gastroesophageal Reflux Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220818
• Other study ID #: C03-043
• Secondary ID: U1111-1114-0294
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: July 20, 2010
• Start date: January 2005
• Est. completion date: July 2005

Study information

• Verified date: July 2010
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

A Phase 1, multicenter, pharmacokinetic/Pharmacodynamic and safety study in which infants will be randomized in an open-label fashion to receive 5 days of open-label treatment with lansoprazole pediatric suspension 1 mg/kg/day oral, or lansoprazole pediatric suspension 2 mg/kg/day oral. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 364 Days

Eligibility

Inclusion Criteria:

• Hospitalized or outpatient male or female, term or post-term infants beyond the neonatal period (>28 days) but less than 12 months of age, OR a preterm infant with a corrected age of at least 44 weeks but less than 12 months on Dosing Day 1.

• Clinically-evident Gastroesophageal Reflux Disease (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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Lansoprazole
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
• Lansoprazole
Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Analysis.		Day 1 and 5	No
Primary	Mean Intragastric 24 hour pH (subset of 6 subjects)		Day -1, 1 and 5	No
Secondary	Gastroesophageal Reflux Disease Symptom Assessment.		Days 1-5	No

External Links

•   FDA Safety Alerts and Recalls