Gastroesophageal Reflux DiseasePhase 1NCT00174928
A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease
A Phase 1 study testing Lansoprazole in people with Gastroesophageal Reflux Disease, run by Takeda.
Trial summary
The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Aug 2005
- Phase
- Phase 1
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates in the Neonatal Intensive Care or Special Care Nursery who have been fed orally or by feeding tube.
- Term or post-term infants with a body weight of >800 gms.
- Pre-term infants with a corrected age of less than 44 weeks.
- Clinically-evident GERD (feeding intolerance, regurgitation, wheezing or stridor with feedings)
- At least 7 days post-surgery without anticipated need for surgery during study
- No significant laboratory abnormalities
Who cannot join
- Unstable, clinically significant disease or abnormality
- Congenital anomaly of the upper gastrointestinal tract
- Clinical evidence of acute sepsis
- Cystic fibrosis
- Medical condition requiring subject to not be fed by mouth/gastric tube
About this study
Official title: A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multi-center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Neonates With Clinically-Evident Gastroesophageal Reflux Disease.
The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.
Read the detailed description
A Phase 1, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansoprazole pediatric suspension 1.0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day orally. On dosing Days 1 and 5, blood samples will be obtained for drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring, provided it is clinically indicated, at the discretion of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at baseline, on dosing Day 1 (or Day 2) and on dosing Day 5 (or Day 6). Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated for safety, including a follow-up visit on post-dosing Day 14.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Lansoprazole
- Keywords
- Pediatric GERD, Pediatric Gastroesophageal Reflux Disease, Neonates, 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
Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.
LansoprazoleDrug
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole 0.5 mg/kg QD | Experimental | Not described Receives: Drug: Lansoprazole |
| Lansoprazole 1.0 mg/kg QD | Experimental | Not described Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Analysis
Measured: Day 1 and 5
Mean Intragastric 24 hour pH (subset of six subjects)
Measured: Day -1, Day 1 and Day 5
Secondary outcomes (1)
Gastroesophageal Reflux Disease Symptom Analysis
Measured: Days 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174928
- Sponsor's protocol ID
- C03-042
- Other IDs
- U1111-1113-9957
- Status last verified
- Jul 2010
- First submitted
- 9 Sep 2005
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Springer M, Atkinson S, North J, Raanan M. Safety and pharmacodynamics of lansoprazole in patients with gastroesophageal reflux disease aged <1 year. Paediatr Drugs. 2008;10(4):255-63. doi: 10.2165/00148581-200810040-00004.
PubMed 18590344Zhang W, Kukulka M, Witt G, Sutkowski-Markmann D, North J, Atkinson S. Age-dependent pharmacokinetics of lansoprazole in neonates and infants. Paediatr Drugs. 2008;10(4):265-74. doi: 10.2165/00148581-200810040-00005.
PubMed 18590345
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multi-center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Neonates With Clinically-Evident Gastroesophageal Reflux Disease.
- ClinicalTrials.gov ID
- NCT00174928
- Acronym / sponsor ID
- C03-042
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Pediatric GERD, Pediatric Gastroesophageal Reflux Disease, Neonates, lansoprazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 15 Sep 2005 (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.
The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.
Detailed description
A Phase 1, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansoprazole pediatric suspension 1.0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day orally. On dosing Days 1 and 5, blood samples will be obtained for drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring, provided it is clinically indicated, at the discretion of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at baseline, on dosing Day 1 (or Day 2) and on dosing Day 5 (or Day 6). Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated for safety, including a follow-up visit on post-dosing Day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole 0.5 mg/kg QD | Experimental | Drug: Lansoprazole |
| Lansoprazole 1.0 mg/kg QD | Experimental | Drug: Lansoprazole |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Neonates in the Neonatal Intensive Care or Special Care Nursery who have been fed orally or by feeding tube.
- Term or post-term infants with a body weight of >800 gms.
- Pre-term infants with a corrected age of less than 44 weeks.
- Clinically-evident GERD (feeding intolerance, regurgitation, wheezing or stridor with feedings)
- At least 7 days post-surgery without anticipated need for surgery during study
Key exclusion criteria (5 listed)
- Unstable, clinically significant disease or abnormality
- Congenital anomaly of the upper gastrointestinal tract
- Clinical evidence of acute sepsis
- Cystic fibrosis
- Medical condition requiring subject to not be fed by mouth/gastric tube
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 |
|---|---|---|
| LansoprazoleLansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days. | Drug | Lansoprazole 0.5 mg/kg QD |
| LansoprazoleLansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days. | Drug | Lansoprazole 1.0 mg/kg QD |
Primary outcome
Pharmacokinetic Analysis
Time frame: Day 1 and 5
Mean Intragastric 24 hour pH (subset of six subjects)
Time frame: Day -1, Day 1 and Day 5
1 secondary outcome
Gastroesophageal Reflux Disease Symptom Analysis
Time frame: Days 1-5
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 22 Jul 2010.
- Results publication: PubMed 18590344Springer M, Atkinson S, North J, Raanan M. Safety and pharmacodynamics of lansoprazole in patients with gastroesophageal reflux disease aged <1 year. Paediatr Drugs. 2008;10(4):255-63. doi: 10.2165/00148581-200810040-00004.
- Results publication: PubMed 18590345Zhang W, Kukulka M, Witt G, Sutkowski-Markmann D, North J, Atkinson S. Age-dependent pharmacokinetics of lansoprazole in neonates and infants. Paediatr Drugs. 2008;10(4):265-74. doi: 10.2165/00148581-200810040-00005.
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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.
Medical Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lansoprazole in people with Gastroesophageal Reflux Disease, run by Takeda.
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 6 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 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
Pharmacokinetic Analysis (time frame: Day 1 and 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00174928, which also lists 2 linked publications.
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 22 Jul 2010.