A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
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ClinicalTrials.gov Identifier: NCT00220818 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: July 22, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux Disease | Drug: Lansoprazole | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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. |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | July 2005 |
Actual Study Completion Date : | July 2005 |

Arm | Intervention/treatment |
---|---|
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.
|
- Pharmacokinetic Analysis. [ Time Frame: Day 1 and 5 ]
- Mean Intragastric 24 hour pH (subset of 6 subjects) [ Time Frame: Day -1, 1 and 5 ]
- Gastroesophageal Reflux Disease Symptom Assessment. [ Time Frame: Days 1-5 ]

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Ages Eligible for Study: | up to 364 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220818
Study Director: | Medical Director | Takeda |
Additional Information:
Publications of Results:
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 ( Registry Identifier: WHO ) |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | July 22, 2010 |
Last Verified: | July 2010 |
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 |