A Phase 1 interventional study of Lansoprazole and Lansoprazole in Gastroesophageal Reflux Disease, sponsored by Takeda. Completed. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2010-07-22.
Sponsored by Takeda · Phase 1, Interventional, and Treatment
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.
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 24 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Lansoprazole
Drug: Lansoprazole
Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.
Lansoprazole 1.0 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 six subjects)
Time frame: Day -1, Day 1 and Day 5
Gastroesophageal Reflux Disease Symptom Analysis
Time frame: Days 1-5
No study locations are listed for this record.
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Takeda