Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642602
• Other study ID #: TAK-390MR_206
• Secondary ID: U1111-1128-59772
• Status: Completed
• Phase: Phase 2
• First received: July 12, 2012
• Last updated: July 14, 2014
• Start date: July 2012
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: Ministry of HealthMexico: Ministry of HealthBelgium: Federal Agency for Medicinal Products and Health ProductsItaly: The Italian Medicines AgencyBulgaria: Ministry of HealthPoland: Ministry of HealthHungary: National Institute of PharmacyPortugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux disease (GERD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

1. In the opinion of the investigator, the participant 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 participant, respectively.

3. The participant 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 participant 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 participant 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 participant is male or female and aged 12 to 17 years, inclusive.

7. A male participant 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 participant 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.

Exclusion Criteria:

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

2. The participant 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 participant has a known history of Barrett's with dysplastic changes in the esophagus.

4. The participant has a known history of eosinophilic esophagitis (EoE) or endoscopic findings suggestive of EoE.

5. The participant has a history of celiac disease or the participant tests positive for tTG antibody.

6. The participant has active gastric or duodenal ulcers within 4 weeks prior to Day -1.

7. Participant 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. Participant has taken any PPI within 1 week (7 days) prior to the Screening Visit.

9. The participant 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 participant is required to take excluded medications or it is anticipated that the participant 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 participant has a history of malignant disease (except basal cell carcinoma) within 5 years prior to Screening.

12. The participant has a condition that may require inpatient surgery during the course of the study.

13. The participant 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 participant is known to be positive for human immunodeficiency virus (HIV).

15. The participant has current or clinical history of Zollinger-Ellison syndrome or other hypersecretory condition.

16. The participant 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 participant had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.

18. The participant 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 participant 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. The participant has any Screening Visit 1 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. If female, the participant is pregnant or lactating or intending to become pregnant before, during or within 30 days after last dose of study medication; or intending to donate ova during such time period.

22. If male, the participant intends to donate sperm during the course of this study or within 30 days after last dose of study drug.

23. The participant, participant's Parent(s) or Legal Guardian 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 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.

24. The participant or participant's Parent(s) or Legal Guardian, in the opinion of the investigator, is unlikely to comply with the protocol requirements or is unsuitable for any other reason.

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Dexlansoprazole
Dexlansoprazole delayed-release capsules.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Hungary,  Italy,  Mexico,  Poland,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by =5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period	A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.	4 weeks	Yes
Secondary	The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment	Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary.	4 weeks	No

External Links

•   Dexilant Package Insert
•   FDA Safety Alerts and Recalls