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Also known as Lansoprazole microgranules suspension
Lansoprazole microgranules · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Lansoprazole QD | EXPERIMENTAL | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Lansoprazole microgranules suspension | DRUG | Lansoprazole microgranules 0.2-0.3 mg/kg/day suspension, orally, once daily for up to 28 days for infants less than 10 weeks; Lansoprazole microgranules 1.0-1.5 mg/kg/day suspension, orally, once daily for up to 28 days for infants greater than 10 weeks. |
| Placebo | DRUG | Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days. |
Inclusion Criteria: * At least 7 days post-surgery at the time of Screening (Study Visit 1) with no anticipated need for surgery during the study. * Experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or "spitting up," fussing/irritability, feeding refusal, crying duri...
Lansoprazole microgranules is a small-molecule formulation of lansoprazole, a proton pump inhibitor developed by Takeda Pharmaceutical Company Limited (TAK). It is being studied in a Phase 3 program for gastroesophageal reflux disease, and it is also known as lansoprazole microgranules suspension.
Lansoprazole microgranules is being developed for gastroesophageal reflux disease, a gastrointestinal condition. The Phase 3 trial in this program evaluated the use of lansoprazole to treat infants with symptoms of gastroesophageal reflux, so the studied population was pediatric.
Lansoprazole microgranules targets ATP4A and ATP4B, the subunits of the gastric proton pump, and acts as an inhibitor of that target. By inhibiting this pump, the drug is designed to reduce gastric acid secretion, which is the mechanism relevant to gastroesophageal reflux disease.
Lansoprazole microgranules is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor behind the clinical development program for this formulation in gastroesophageal reflux disease.
Lansoprazole microgranules is in Phase 3 development. It is an investigational formulation and is not described as approved. The program includes one completed Phase 3 trial, with no active trials currently listed, and a total enrollment of 162 participants.
Lansoprazole microgranules has been studied in the completed Phase 3 trial NCT00324974, titled "The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux." That randomized, double-blind, placebo-controlled trial enrolled 162 participants across the United States and Poland.