Preterm InfantsPhase 2NCT01778101
Lansoprazole in Preterm Infants With Reflux
A Phase 2 study testing Lansoprazole in people with Preterm Infants and Gastrointestinal Reflux, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Preterm Infants, Gastrointestinal Reflux
- What is being tested?
- Lansoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jun 2013
- Phase
- Phase 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 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infant
- documented gastrointestinal reflux by 24hr pH monitoring
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 110-740
About this study
Official title: 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
- Conditions
- Preterm Infants, Gastrointestinal Reflux
- Being tested
- Lansoprazole
- Keywords
- preterm infants, reflux, impedance, pH, monitoring, lansoprazole
- Medical subject headings
- 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
lansoprazole 1mg/kg twice a day for 14days
| Study group | Role | What they receive |
|---|---|---|
| lansoprazole | Experimental | lansoprazole 1mg/kg twice a day for 14days Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
impedance pH monitoring
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
Measured: day14
Secondary outcomes (5)
Symtomts of reflux_d5
apnea bradycardia desaturation regurgitate vomiting
Measured: day 5
impedance pH monitoring_d10
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
Measured: day10
impedance pH monitoring_d5
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
Measured: day5
Symtomts of reflux_d10
apnea bradycardia desaturation regurgitate vomiting
Measured: day 10
Symtomts of reflux_d14
apnea bradycardia desaturation regurgitate vomiting
Measured: Symtomts of reflux_d14 day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT01778101
- Sponsor's protocol ID
- Lanso_pilot
- Other IDs
- 0720120860
- Status last verified
- Sep 2013
- First submitted
- 13 Jan 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT01778101
- Acronym / sponsor ID
- Lanso_pilot
- Conditions
- Preterm Infants, Gastrointestinal Reflux
- Keywords
- preterm infants, reflux, impedance, pH, monitoring, lansoprazole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jan 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 pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lansoprazole | Experimental | Drug: Lansoprazolelansoprazole 1mg/kg twice a day for 14days |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preterm infant
- documented gastrointestinal reflux by 24hr pH monitoring
Key exclusion criteria (6 listed)
- 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
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 LFDTlansoprazole 1mg/kg twice a day for 14days | Drug | lansoprazole |
Primary outcome
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
5 secondary outcomes
Symtomts of reflux_d5
Time frame: day 5
impedance pH monitoring_d10
Time frame: day10
impedance pH monitoring_d5
Time frame: day5
Symtomts of reflux_d10
Time frame: day 10
Symtomts of reflux_d14
Time frame: Symtomts of reflux_d14 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 13 Sep 2013.
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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 2 study testing Lansoprazole in people with Preterm Infants and Gastrointestinal 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 6 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 13 Sep 2013. 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 phase mean?
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?
impedance pH monitoring (time frame: day14). 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 13 Sep 2013.