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A Phase 2 Study of Dexlansoprazole Delayed-Release Capsules to Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Pediatric Subjects Aged 2 to 11 Years
EU CTIS ID: 2022-501349-64-00
What this study is testing
To assess the safety and effectiveness of treatment with QD oral administration of dexlansoprazole delayed release capsules (15,30, and 60 mg) in pediatric subjects aged 2 to 11 years with symptomatic nonerosive GERD
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Medical history of GERD symptoms for at least 3 months prior to Screening.
- Reported symptoms of hurting or burning in the stomach, chest, or throat on at least 3 out of any 7 consecutive days as recorded in the eDiary during screening.
- No evidence of erosive esophagitis according to the LA Classification of Esophagitis and, in the investigator's clinical judgment, the symptoms are suggestive of acid-related disease. A 24-hour pH-metry (with or without impedance) may be performed during Screening or within 6 months prior to Screening for similar symptoms as those identified during Screening if, in the investigator's judgment, this procedure would aid in the determination of whether the subject's symptoms are acid related.
You likely can't join if
- Erosive esophagitis.
- History of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or antacid or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole).
- Evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergic skin rash that suggests any uncontrolled, clinically significant underlying disease or condition (other than the disease being studied), which may impact the ability of the subject to participate or potentially confound the study results.
- Any findings in medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.
- Known history of Barrett's esophagus with dysplastic changes in the esophagus.
- History of the following: eosinophilic esophagitis (EoE) or histologic findings suggestive of EoE (>15 eosinophils per high-powered field [HPF]); a history of celiac disease or tests positive for tissue transglutaminase (tTG) antibody or confirmed disease by histology; inflammatory bowel disease; or irritable bowel syndrome.
See the full eligibility criteria
- Medical history of GERD symptoms for at least 3 months prior to Screening.
- Reported symptoms of hurting or burning in the stomach, chest, or throat on at least 3 out of any 7 consecutive days as recorded in the eDiary during screening.
- No evidence of erosive esophagitis according to the LA Classification of Esophagitis and, in the investigator's clinical judgment, the symptoms are suggestive of acid-related disease. A 24-hour pH-metry (with or without impedance) may be performed during Screening or within 6 months prior to Screening for similar symptoms as those identified during Screening if, in the investigator's judgment, this procedure would aid in the determination of whether the subject's symptoms are acid related.
- Erosive esophagitis.
- History of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or antacid or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole).
- Evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergic skin rash that suggests any uncontrolled, clinically significant underlying disease or condition (other than the disease being studied), which may impact the ability of the subject to participate or potentially confound the study results.
- Any findings in medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.
- Known history of Barrett's esophagus with dysplastic changes in the esophagus.
- History of the following: eosinophilic esophagitis (EoE) or histologic findings suggestive of EoE (>15 eosinophils per high-powered field [HPF]); a history of celiac disease or tests positive for tissue transglutaminase (tTG) antibody or confirmed disease by histology; inflammatory bowel disease; or irritable bowel syndrome.
- Active gastric or duodenal ulcers within 4 weeks prior to Day -1.
- Subjects who are required to take prescription or nonprescription medications as listed in Excluded Medications and Treatment Section of the protocol (Section 7.3).
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- United States
- Mexico
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; United States; Mexico; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.