Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Open Label Run In Esomeprazole · 1 trial · 1 indication
Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.
| Arm | Type | Description |
|---|---|---|
| Open Label Esomeprazole | EXPERIMENTAL | This is an open label, run-in phase. All patients received Esomeprazole. |
| Double Blind Esomeprazole | EXPERIMENTAL | This is the double blind withdrawal phase. Patients are randomized to active drug or placebo. |
| Double Blind Placebo | PLACEBO_COMPARATOR | This is the double blind withdrawal phase. Patients are randomized to active drug or placebo. |
| Name | Type | Description |
|---|---|---|
| Open Label Run In Esomeprazole | DRUG | Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) |
| Double Blind Esomeprazole | DRUG | Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) |
| Double Blind Placebo | DRUG | Double Blind Placebo |
Inclusion Criteria: * patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations) * patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test cal...
Open Label Run In Esomeprazole is used for Gastroesophageal Reflux Disease (GERD) in infants. It is a small molecule being developed by AstraZeneca PLC. The drug is currently in Phase 3 clinical development and is being studied for its safety and efficacy in this patient population.
Open Label Run In Esomeprazole is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting a Phase 3 clinical trial to evaluate the drug's safety and efficacy in infants with Gastroesophageal Reflux Disease (GERD).
Open Label Run In Esomeprazole is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of Gastroesophageal Reflux Disease (GERD) in infants. The drug has not been approved and remains under clinical investigation.
Open Label Run In Esomeprazole is associated with one completed Phase 3 clinical trial, NCT00468559, titled 'Phase 3/Safety & Efficacy of Esomeprazole in Infants'. This trial enrolled 98 participants with Gastroesophageal Reflux Disease (GERD) and was conducted in the United States, France, Germany, and Poland.
Open Label Run In Esomeprazole is a formulation of esomeprazole, a proton pump inhibitor. The clinical trial NCT00468559 evaluates esomeprazole in infants with Gastroesophageal Reflux Disease (GERD). The drug is being developed by AstraZeneca PLC and is currently in Phase 3 development.