A Phase 2 Study of Dexlansoprazole Delayed-Release Capsules to Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Pediatric Subjects Aged 1 to 11 Years

• Status: Not yet recruiting
• Trial end date: 2025-01-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and effectiveness of treatment with once daily (QD) oral administration of dexlansoprazole capsules (15, 30, and 60 mg) in pediatric participants aged 1 to 11 years with symptomatic nonerosive gastroesophageal reflux disease (GERD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

1. In the opinion of the investigator, the participant (as age appropriate) and/or parent(s)/legal guardian is capable of understanding and complying with protocol requirements.

2. Prior to any study-specific procedures being performed, the informed consent and the assent form (as applicable) must be signed and dated by parent(s) or legal guardian and by the participant respectively, if appropriate.

3. Has a medical history of symptoms of gastroesophageal reflux disease (GERD) for at least 3 months prior to Screening.

4. Has a medical history of at least 1 failed attempted withdrawal of prior proton pump inhibitor (PPI)/acid suppressive therapy and a return of symptoms upon withdrawal.

5. Has met the electronic diary (eDiary) qualification criteria as assessed by the Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD), defined as hurting or burning in the stomach, chest, or throat on at least 3 of any 7 consecutive days during the Screening Period.

6. Has either (1) a positive endoscopy with both a Hetzel-Dent (HD) Grade 1 and a Histologic Features of Reflux Esophagitis (HFRE) Scale Grade <2, OR (2) an endoscopy with HD Grade 0 and a documented pH-metry suggestive of acid-related disease. The pH-metry should be performed during Screening or within 6 months of signing informed consent and assent (as applicable) for GERD symptoms. An endoscopy performed within 1 week prior to signing informed consent and assent (as applicable), is an acceptable replacement for the screening endoscopy if GERD is documented by the HD classification scale criterion previously described, protocol-required biopsies were collected and endoscopic pictures were obtained.

7. Is male or female and age 1 to 11 years inclusive at Screening.

Exclusion Criteria:

1. Has 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 participant to participate or potentially confound the study results.

2. Has a coexisting disease affecting the esophagus (eg, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.

3. Has any findings in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.

4. Has a history of hypersensitivity or allergies to dexlansoprazole, any component of dexlansoprazole or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole) or antacids.

5. Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period.

6. Has a condition that may require inpatient surgery during the course of the study.

7. Has known history of Barrett's esophagus with dysplastic changes in the esophagus.

8. Has history of eosinophilic esophagitis (EoE) endoscopic or histologic findings suggestive of EoE (>15 eosinophils per high-powered field [HPF])

9. Has history of celiac disease, tests positive for tissue transglutaminase (tTG) antibody or confirmed disease by histology.

10. Has history of inflammatory bowel disease, or irritable bowel syndrome.

11. Has active gastric or duodenal ulcers within 4 weeks prior to Day -1.

12. Requires dilatation of esophageal strictures and/or strictures preventing passage of the endoscope during the screening endoscopy. Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) is acceptable.

13. A female participant who has reached menarche.

14. Is known to be positive for the human immunodeficiency virus (HIV).

15. Has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.

16. Has a history of gastric, duodenal, or esophageal surgery except simple oversew of an ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG) placement is allowed.

17. Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.

18. Has donated or lost >10% of the total blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.

19. Has a known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug.

20. Has any screening abnormal laboratory value that suggests a clinically significant underlying disease or condition that may prevent the participant from entering the study; or the participant has: creatinine >1.5 mg/dL, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times the upper limit of normal (×ULN), or total bilirubin >2.0 mg/dL with AST/ALT elevated above the limits of normal values.

21. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study or may consent and assent (as applicable) under duress. Students of the institution/research facility who are under the supervision of, or in a subordinate role to, the investigator are also ineligible.

22. The participant, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

23. Has participated in another clinical study and/or has received any investigational compound within 30 days prior to Screening.