Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents
Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease
Intervention: Dexlansoprazole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Takeda Official(s) and/or principal investigator(s): Medical Director Clinical Science, Study Director, Affiliation: Takeda Global Research and Development Center, Inc.
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).
Clinical Details
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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period
Secondary outcome: The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Bruxelles, Belgium
Debrecen, Hungary
Györ, Hungary
Miskolc, Hungary
Nyiregyhaza, Hungary
Pecs, Hungary
Veszprem, Hungary
Bari, Italy
Messina, Italy
Roma, Italy
Bydgoszcz, Poland
Krakow, Poland
Rzeszow, Poland
Szczecin, Poland
Torun, Poland
Warszawa, Poland
Wroclaw, Poland
Amadora, Portugal
Braga, Portugal
Coimbra, Portugal
Lisboa, Portugal
Porto, Portugal
Huntsville, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Los Angeles, California, United States
San Francsco, California, United States
Centennial, Colorado, United States
Thornton, Colorado, United States
Mexico, Distrito Federal, Mexico
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Flint, Michigan, United States
Plymouth, Minnesota, United States
Jackson, Mississippi, United States
Kansas City, Missouri, United States
Mays Landing, New Jersey, United States
Brooklyn, New York, United States
Huntsville, North Carolina, United States
Monterrey, Nuevo León, Mexico
Toledo, Ohio, United States
Youngstown, Ohio, United States
Passo Fundo, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Santo Andre, Sao Paulo, Brazil
Santo André, Sao Paulo, Brazil
São José do Rio Preto, Sao Paulo, Brazil
Culiacan, Sinaloa, Mexico
Greenville, South Carolina, United States
Kingsport, Tennessee, United States
Ft. Worth, Texas, United States
Houston, Texas, United States
Laredo, Texas, United States
San Antonio, Texas, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Additional Information
Dexilant Package Insert FDA Safety Alerts and Recalls
Starting date: July 2012
Last updated: July 14, 2014
|