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Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01946971
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
10
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Lansoprazole in Preterm Infants With Gastroesophageal Reflux
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: PL

Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days

Drug: Lansoprazole
Other Names:
  • lanston LFDT

    • Drug: Placebo
    Experimental: LP

    Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days

    Drug: Lansoprazole
    Other Names:
  • lanston LFDT

    • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Acid reflux time (%) [day 0, day 7, day 14]

      measured by 24hr pH impedance monitor

    Secondary Outcome Measures

    1. Acid reflux frequency [day 0, day 7, day 14]

      measured by 24hr pH impedance monitor

    2. Composite score [day 0, day 7, day 14]

      measured by 24hr pH impedance monitor

    3. Acid reflux fraction [day 0, day 7, day 14]

      measured by 24hr pH impedance monitor

    4. acid bolus reflux time/%, [day 0, day 7, day 14]

      measured by 24hr pH impedance monitor

    5. nonacid bolus reflux time/% [day 0, day 7, day 14]

      measured by 24hr pH impedance monitor

    6. bolus reflux time/% [day 0, day 7, day 14]

      measured by 24hr pH impedance monitor

    7. I-GERQ GERD score [day 0, day 7, day 14]

      I-GERQ GERD score chart (Infant Gastroesophageal Reflux Questionnaire Gastroesophageal Reflux Disease)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 6 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-740

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Han-Suk Kim, MD, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han-Suk Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01946971
    Other Study ID Numbers:
    • Konect-LASP
    First Posted:
    Sep 20, 2013
    Last Update Posted:
    Nov 19, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esophagitis, Peptic
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of Nov 19, 2014