Premature InfantsPhase 1/2NCT01946971
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
A Phase 1/2 study testing Lansoprazole in people with Premature Infants and Gastroesophageal Reflux, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Premature Infants, Gastroesophageal Reflux
- What is being tested?
- Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Jul 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infant
- symptoms suspecting gastroesophageal reflux
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lansoprazole in Preterm Infants With Gastroesophageal Reflux
This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.
- Conditions
- Premature Infants, Gastroesophageal Reflux
- Being tested
- Lansoprazole, Placebo
- Medical subject headings
- Premature Birth, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Also called lanston LFDT
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PL | Experimental | Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days Receives: 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 Receives: Drug: Lansoprazole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acid reflux time (%)
measured by 24hr pH impedance monitor
Measured: day 0, day 7, day 14
Secondary outcomes (7)
Acid reflux frequency
measured by 24hr pH impedance monitor
Measured: day 0, day 7, day 14
Composite score
measured by 24hr pH impedance monitor
Measured: day 0, day 7, day 14
Acid reflux fraction
measured by 24hr pH impedance monitor
Measured: day 0, day 7, day 14
acid bolus reflux time/%,
measured by 24hr pH impedance monitor
Measured: day 0, day 7, day 14
nonacid bolus reflux time/%
measured by 24hr pH impedance monitor
Measured: day 0, day 7, day 14
bolus reflux time/%
measured by 24hr pH impedance monitor
Measured: day 0, day 7, day 14
I-GERQ GERD score
I-GERQ GERD score chart (Infant Gastroesophageal Reflux Questionnaire Gastroesophageal Reflux Disease)
Measured: day 0, day 7, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Suk Kim, Seoul National University Hospital
- Investigators
- Han-Suk Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946971
- Sponsor's protocol ID
- Konect-LASP
- Status last verified
- Nov 2014
- First submitted
- 12 Sep 2013
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lansoprazole in Preterm Infants With Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT01946971
- Acronym / sponsor ID
- Konect-LASP
- Conditions
- Premature Infants, Gastroesophageal Reflux
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PL | Experimental | Drug: Lansoprazole, Drug: PlaceboPlacebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days |
| LP | Experimental | Drug: Lansoprazole, Drug: PlaceboLansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preterm infant
- symptoms suspecting gastroesophageal reflux
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LansoprazoleAlso: lanston LFDT | Drug | LP, PL |
| Placebo | Drug | LP, PL |
Primary outcome
Acid reflux time (%)
Time frame: day 0, day 7, day 14
measured by 24hr pH impedance monitor
7 secondary outcomes
Acid reflux frequency
Time frame: day 0, day 7, day 14
Composite score
Time frame: day 0, day 7, day 14
Acid reflux fraction
Time frame: day 0, day 7, day 14
acid bolus reflux time/%,
Time frame: day 0, day 7, day 14
nonacid bolus reflux time/%
Time frame: day 0, day 7, day 14
bolus reflux time/%
Time frame: day 0, day 7, day 14
I-GERQ GERD score
Time frame: day 0, day 7, day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Suk Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lansoprazole in people with Premature Infants and Gastroesophageal Reflux, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acid reflux time (%) (time frame: day 0, day 7, day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.