A Phase 2, Double-Blind, 12 Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules in Pediatric Subjects Aged 2 to 11 Years With Symptomatic Nonerosive Gastroesophageal Reflux Disease

The primary objective of this Phase 2, double-blind, multicenter study is to evaluate the **safety** and **effectiveness** of daily oral administration of dexlansoprazole delayed-release capsules in pediatric subjects aged 2 to 11 years with symptomatic nonerosive gastroesophageal reflux disease (GERD). This study aims to determine the therapeutic impact of dexlansoprazole at doses of 15 mg, 30 mg, and 60 mg over a 12-week period. The clinical relevance of this study lies in its potential to provide a safe and effective treatment option for young children suffering from symptomatic nonerosive GERD, a condition that can significantly impact quality of life and lead to further complications if not adequately managed.

The clinical trial involves a total of **50 participants** who are pediatric subjects aged **2 to 11 years** diagnosed with symptomatic nonerosive **gastroesophageal reflux disease (GERD)**. The study population includes both male and female subjects, and it is noted that the participants are considered a vulnerable population due to their age. Participants were selected based on a medical history of GERD symptoms persisting for at least three months prior to screening, with reported symptoms of discomfort or burning in the stomach, chest, or throat on at least three out of any seven consecutive days. The trial does not include subjects with evidence of erosive esophagitis, as determined by the LA Classification of Esophagitis, and the symptoms must be suggestive of acid-related disease. Lifestyle factors such as diet and physical activity are not specified in the available data. The sponsor has not provided additional information regarding specific lifestyle considerations or other selection criteria beyond the principal inclusion criteria.

The clinical trial is designed as a **randomized**, **double-blind**, and controlled study to evaluate the safety and effectiveness of **dexlansoprazole** delayed-release capsules in pediatric subjects aged 2 to 11 years with symptomatic nonerosive **gastroesophageal reflux disease** (GERD). The trial will span a duration of 12 weeks, during which participants will receive daily oral administration of the investigational product. The study will involve multiple visits, starting with an inclusion (screening) visit to assess eligibility based on criteria such as a medical history of GERD symptoms for at least three months and reported symptoms of hurting or burning in the stomach, chest, or throat on at least three out of any seven consecutive days. Participants will be randomly assigned to receive one of three doses: 15 mg, 30 mg, or 60 mg, with the maximum daily dose not exceeding 60 mg.

Following the screening visit, participants will attend regular follow-up visits to monitor safety and efficacy outcomes, including the percentage of days without symptoms such as hurting or burning in the stomach, chest, or throat, and other secondary endpoints like the percentage of days without vomiting or trouble eating. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the primary endpoint, which is the percentage of days without symptoms over the 12-week treatment period. The expected length of participant involvement is approximately 12 weeks, with conditions for early termination including adverse events or withdrawal of consent. The trial aims to provide valuable data on the use of dexlansoprazole in a pediatric population, contributing to the understanding of its safety and efficacy in treating symptomatic nonerosive GERD.

The clinical trial involves the administration of **Dexlansoprazole Pediatric**, a medication formulated as a **capsule, prolonged release, hard**. This experimental medication is designed for oral use and is intended for pediatric subjects aged 2 to 11 years with symptomatic nonerosive gastroesophageal reflux disease (GERD). The active substance in the medication is **dexlansoprazole**, which is of chemical origin. The trial includes three different dosages of dexlansoprazole: 15 mg, 30 mg, and 60 mg. Each dosage is administered once daily (QD) over a maximum treatment period of 12 weeks. The maximum daily doses are 15 mg, 30 mg, and 60 mg, with corresponding maximum total doses of 1260 mg, 2520 mg, and 5040 mg, respectively. The medication is manufactured by Takeda Development Center Americas, Inc.

In addition to the experimental treatment, the study may include non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatment, although specific details are not provided in the data. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the prescribed regimen. The trial is conducted under a double-blind design to assess the safety and effectiveness of the treatment in the specified pediatric population.

The efficacy of the clinical trial will be assessed through a series of primary and secondary endpoints designed to evaluate the effectiveness of daily oral administration of **dexlansoprazole** delayed-release capsules in pediatric subjects aged 2 to 11 years with symptomatic nonerosive gastroesophageal reflux disease (GERD). The primary endpoint is the percentage of days without experiencing symptoms such as hurting or burning in the stomach, chest, or throat over the 12-week treatment period. This will be measured using patient-reported outcomes recorded in an electronic diary (eDiary) during the trial.

Secondary endpoints include the percentage of days without these symptoms specifically in children aged 9 to 11 years and 2 to 8 years, respectively, over the same period. Additional secondary endpoints involve the percentage of days without vomiting, days when food did not regurgitate from the stomach to the mouth, and days without trouble eating. Furthermore, the trial will compare the difference in the mean percentage of symptom-free days between high and low doses within each weight stratum. These efficacy parameters will be collected and analyzed at the end of the 12-week treatment period to determine the effectiveness of the treatment regimen.