Lansoprazole in Preterm Infants With Gastroesophageal Ref... | NCT01946971

Studies
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

NCT01946971

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Nov 19, 2014Estimated

Enrollment

12Actual

Phase

Phase 1Phase 2

Conditions

Premature Infants
Gastroesophageal Reflux

Interventions

Lansoprazole
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Sep 12, 2013

First Submission Date that Met QC Criteria

Sep 17, 2013

First Posted Date

Sep 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PL	Experimental	Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days	Drug: Lansoprazole Drug: Placebo
LP	Experimental	Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days	Drug: Lansoprazole Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lansoprazole	Drug		LP PL	lanston LFDT
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acid reflux time (%)	measured by 24hr pH impedance monitor	day 0, day 7, day 14

Secondary Outcomes

Measure	Description	Time Frame
Acid reflux frequency	measured by 24hr pH impedance monitor	day 0, day 7, day 14
Composite score	measured by 24hr pH impedance monitor

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Han-Suk Kim, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-740	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064747	Lansoprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided