- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01778101
Lansoprazole in Preterm Infants With Reflux
September 11, 2013 updated by: Han-Suk Kim, Seoul National University Hospital
A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux
This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-740
- Seoul National University Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- preterm infant
- documented gastrointestinal reflux by 24hr pH monitoring
Exclusion Criteria:
- unstable vital sings
- congenital anomaly in upper gastrointestinal tract incuding esophagus
- drug history of H2 blocker during last 1 week
- medication of warfarin, carbamazepine, phenytoin, rifampin
- renal or hepatic dysfunction
- inappropriate clinical conditions judged by researchers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lansoprazole
lansoprazole 1mg/kg twice a day for 14days
|
lansoprazole 1mg/kg twice a day for 14days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
impedance pH monitoring
Time Frame: day14
|
number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability
|
day14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symtomts of reflux_d5
Time Frame: day 5
|
apnea bradycardia desaturation regurgitate vomiting
|
day 5
|
impedance pH monitoring_d10
Time Frame: day10
|
number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability
|
day10
|
impedance pH monitoring_d5
Time Frame: day5
|
number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability
|
day5
|
Symtomts of reflux_d10
Time Frame: day 10
|
apnea bradycardia desaturation regurgitate vomiting
|
day 10
|
Symtomts of reflux_d14
Time Frame: Symtomts of reflux_d14 day 14
|
apnea bradycardia desaturation regurgitate vomiting
|
Symtomts of reflux_d14 day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Han-Suk Kim, MD, PhD, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
January 13, 2013
First Submitted That Met QC Criteria
January 28, 2013
First Posted (Estimate)
January 29, 2013
Study Record Updates
Last Update Posted (Estimate)
September 13, 2013
Last Update Submitted That Met QC Criteria
September 11, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Gastroesophageal Reflux
- Premature Birth
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Dexlansoprazole
- Lansoprazole
Other Study ID Numbers
- Lanso_pilot
- 0720120860 (Other Grant/Funding Number: Konect)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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