4 week study to assess safety and effectiveness of Dexlansoprazole capsules for relief of heartburn in subjects aged 12-17 with symptomatic acid reflux disease.
- Conditions
- Heartburn in Adolescent subjects With Symptomatic Non-Erosive Gastroesophageal Reflux DiseaseMedDRA version: 14.1Level: LLTClassification code 10066874Term: Gastroesophageal reflux diseaseSystem Organ Class: 100000004856MedDRA version: 14.1Level: LLTClassification code 10019326Term: HeartburnSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-001680-72-PT
- Lead Sponsor
- Takeda Development Centre Europe Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Subject eligibility is determined according to the following criteria:
1. In the opinion of the investigator, the subject and parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
2. Prior to any study-specific procedures being performed, the informed consent and the assent form, according to local country requirements, must be signed and dated by parent(s) or legal guardian and by the subject, respectively.
3. The subject has a medical history of symptoms of GERD for at least 3 months prior to Screening (signed informed consent and assent if applicable), as assessed by the investigator.
4. The subject has met the electronic diary qualification criteria as assessed by the electronic daily diary defined as follows: heartburn (burning or hurting in your throat, chest, or stomach) on at least 3 of 7 days.
5. The subject has non-erosive GERD with no evidence of definite endoscopic esophageal mucosal breaks as described in the Los Angeles Classification of Esophagitis at the screening endoscopy
6. The subject is male or female and aged 12 to 17 years, inclusive.
7. A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception* from signing of informed consent and assent throughout the duration of the study and for 30 days after last dose of study medication.
8. A female subject of childbearing potential who is or may become sexually active agrees to routinely use adequate contraception* from the time of signing the informed consent and assent until 30 days after the last dose of study medication.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Any subject who meets any of the following criteria will not qualify for entry into the study:
1. Subject has evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, or metabolic, endocrine or gastrointestinal disease, or serious allergy, asthma, or allergic skin rash that suggests clinically significant, uncontrolled 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.
2. The subject has a co-existing 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. The subject has a known history of Barrett’s with dysplastic changes in the esophagus.
4. The subject has a known history of eosinophilic esophagitis (EoE) or endoscopic findings suggestive of EoE.
5. The subject has a history of celiac disease or the subject tests positive for tTG antibody.
6. The subject has active gastric or duodenal ulcers within 4 weeks prior to Day -1.
7. Subject has any finding 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.
8. Subject has taken any PPI within 1 week (7 days) prior to the Screening Visit.
9. The subject has a history of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole or antacid containing Mg(OH)2 and / or Al (OH)3 or simethicone.
10. The subject is required to take excluded medications or it is anticipated that the subject will require treatment with at least one of the disallowed concomitant medications during the study evaluation period as specified in the Excluded Medications and Treatments Section 7.3.
11. The subject has a history of malignant disease (except basal cell carcinoma) within 5 years prior to Screening.
12. The subject has a condition that may require inpatient surgery during the course of the study.
13. The subject 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.
14. The subject is known to have acquired immunodeficiency syndrome.
15. The subject has current or clinical history of Zollinger-Ellison syndrome or other hypersecretory condition.
16. The subject 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. The subject had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.
18. The subject has donated or lost >/= 300 mL 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. The subject has a known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug, or is unwilling to agree to abstain from alcohol or illegal drug use throughout the study.
20. The subject has any Screening Visit 1 abnormal laboratory va
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method