A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
This study has been completed.
Sponsor:
Takeda
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00220818
First received: September 9, 2005
Last updated: July 20, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Drug: Lansoprazole |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Infants With Clinically-Evident Gastroesophageal Reflux Disease. |
Resource links provided by NLM:
Further study details as provided by Takeda:
Primary Outcome Measures:
- Pharmacokinetic Analysis. [ Time Frame: Day 1 and 5 ] [ Designated as safety issue: No ]
- Mean Intragastric 24 hour pH (subset of 6 subjects) [ Time Frame: Day -1, 1 and 5 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Gastroesophageal Reflux Disease Symptom Assessment. [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | January 2005 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lansoprazole 1.0 mg/kg QD |
Drug: Lansoprazole
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
|
| Experimental: Lansoprazole 2.0 mg/kg QD |
Drug: Lansoprazole
Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.
|
Detailed Description:
A Phase 1, multicenter, pharmacokinetic/Pharmacodynamic and safety study in which infants will be randomized in an open-label fashion to receive 5 days of open-label treatment with lansoprazole pediatric suspension 1 mg/kg/day oral, or lansoprazole pediatric suspension 2 mg/kg/day oral. 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.
Eligibility| Ages Eligible for Study: | up to 364 Days (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Hospitalized or outpatient male or female, term or post-term infants beyond the neonatal period (>28 days) but less than 12 months of age, OR a preterm infant with a corrected age of at least 44 weeks but less than 12 months on Dosing Day 1.
- Clinically-evident Gastroesophageal Reflux Disease (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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220818
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220818
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Medical Director | Takeda |
More Information
Additional Information:
Publications:
| Responsible Party: | Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00220818 History of Changes |
| Other Study ID Numbers: | C03-043 U1111-1114-0294 |
| Study First Received: | September 9, 2005 |
| Last Updated: | July 20, 2010 |
| Health Authority: | United States: Food and Drug Administration Poland: Ministry of Health |
Keywords provided by Takeda:
|
Pediatric GERD Pediatric Gastroesophageal Reflux Disease lansoprazole |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Lansoprazole |
Dexlansoprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016