Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

Gastroesophageal Reflux Clinical Trial

Official title:

Lansoprazole in Preterm Infants With Gastroesophageal Reflux

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946971
• Other study ID #: Konect-LASP
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2013
• Last updated: November 17, 2014
• Start date: September 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review BoardKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• preterm infant

• symptoms suspecting gastroesophageal reflux

Exclusion Criteria:

• unstable general conditions due infection or acute illness

• congenital anomaly in upper gastrointestinal tract including esophagus

• drug history of H2, proton pump inhibitor, blocker during last 1 week

• medication of warfarin, carbamazepine, phenytoin, rifampin

• inappropriate clinical conditions judged by researchers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Premature Infants

Intervention

Drug:
• Lansoprazole

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acid reflux time (%)	measured by 24hr pH impedance monitor	day 0, day 7, day 14	No
Secondary	Acid reflux frequency	measured by 24hr pH impedance monitor	day 0, day 7, day 14	No
Secondary	Composite score	measured by 24hr pH impedance monitor	day 0, day 7, day 14	No
Secondary	Acid reflux fraction	measured by 24hr pH impedance monitor	day 0, day 7, day 14	No
Secondary	acid bolus reflux time/%,	measured by 24hr pH impedance monitor	day 0, day 7, day 14	No
Secondary	nonacid bolus reflux time/%	measured by 24hr pH impedance monitor	day 0, day 7, day 14	No
Secondary	bolus reflux time/%	measured by 24hr pH impedance monitor	day 0, day 7, day 14	No
Secondary	I-GERQ GERD score	I-GERQ GERD score chart (Infant Gastroesophageal Reflux Questionnaire Gastroesophageal Reflux Disease)	day 0, day 7, day 14	No