Medidata Solutions ((MDSO)), AstraZeneca ((AZN)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study.
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Medidata Solutions and AstraZeneca are collaborating on a Phase III clinical study titled ‘A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age.’ The study aims to evaluate the safety and efficacy of Nexium in maintaining healing of erosive esophagitis in children aged 1 to 11, a condition not yet approved for treatment in the US.
The intervention involves two doses of Nexium, a drug known for its gastro-resistant properties. The study compares a high dose (20mg) and a low dose (10mg) to determine their effectiveness in maintaining healing over a 16-week period.
This interventional study is randomized with a parallel assignment model and quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocation. The primary goal is to assess treatment efficacy.
The study began on July 1, 2022, and is currently recruiting participants. The primary completion date is set for July 28, 2025, which is also the date of the last update. These dates are crucial for tracking the study’s progress and potential market impact.
The outcome of this study could significantly influence AstraZeneca’s market position, particularly if Nexium gains approval for pediatric use in the US. Positive results may boost investor confidence and stock performance, while also affecting competitors in the pediatric gastroenterology market.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.