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

NCT01642602 | Completed Phase 2 Results

• 3 other identifiers: TAK-390MR_206U1111-1128-59772012-001680-72
• Study Type: interventional
• Target: 104
• Locations: 8 countries
• Sites: 64

Brief 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).

Conditions

Gastroesophageal Reflux Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment

  4 weeks

Study Arms (1)

Dexlansoprazole 30 mg

EXPERIMENTAL

Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.

Drug: Dexlansoprazole

Interventions

Dexlansoprazole DRUG

Dexlansoprazole delayed-release capsules.

Also known as: Dexilant, TAK-390MR

Dexlansoprazole 30 mg

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• In the opinion of the investigator, the participant and parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
• 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.
• 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.
• 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.
• 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
• The participant is male or female and aged 12 to 17 years, inclusive.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• The participant has a known history of Barrett's with dysplastic changes in the esophagus.
• The participant has a known history of eosinophilic esophagitis (EoE) or endoscopic findings suggestive of EoE.
• The participant has a history of celiac disease or the participant tests positive for tTG antibody.
• The participant has active gastric or duodenal ulcers within 4 weeks prior to Day -1.
• 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.
• Participant has taken any PPI within 1 week (7 days) prior to the Screening Visit.
• 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.
• 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.
• The participant has a history of malignant disease (except basal cell carcinoma) within 5 years prior to Screening.
• The participant has a condition that may require inpatient surgery during the course of the study.
• 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.
• The participant is known to be positive for human immunodeficiency virus (HIV).
• The participant has current or clinical history of Zollinger-Ellison syndrome or other hypersecretory condition.

Sponsors & Collaborators

• Takeda: lead

Study Sites (64)

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Los Angeles, California, United States

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San Francsco, California, United States

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Centennial, Colorado, United States

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Thornton, Colorado, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Park Ridge, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Flint, Michigan, United States

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Plymouth, Minnesota, United States

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Jackson, Mississippi, United States

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Kansas City, Missouri, United States

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Mays Landing, New Jersey, United States

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Brooklyn, New York, United States

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Huntsville, North Carolina, United States

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Toledo, Ohio, United States

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Youngstown, Ohio, United States

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Greenville, South Carolina, United States

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Kingsport, Tennessee, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Laredo, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Fairfax, Virginia, United States

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Norfolk, Virginia, United States

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Brussels, Belgium

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Passo Fundo, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Santo André, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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Debrecen, Hungary

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Győr, Hungary

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Miskolc, Hungary

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Nyíregyháza, Hungary

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Pécs, Hungary

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Veszprém, Hungary

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Bari, Bari, Italy

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Messina, Messina, Italy

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Roma, Roma, Italy

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Culiacán, Sinaloa, Mexico

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Bydgoszcz, Poland

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Krakow, Poland

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Rzeszów, Poland

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Szczecin, Poland

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Torun, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Amadora, Portugal

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Braga, Portugal

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Coimbra, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Related Publications (1)

• Gold BD, Pilmer B, Kierkus J, Hunt B, Perez MC, Gremse D. Dexlansoprazole for Heartburn Relief in Adolescents with Symptomatic, Nonerosive Gastro-esophageal Reflux Disease. Dig Dis Sci. 2017 Nov;62(11):3059-3068. doi: 10.1007/s10620-017-4743-3. Epub 2017 Sep 15.

  PMID: 28916953 DERIVED

Related Links

• Dexilant Package Insert

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Dexlansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director Clinical Science

  Takeda Global Research and Development Center, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 6, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-07

Locations

PT (5); BR (4); ME (3); BE (1); HU (6); IT (3); PL (7); US (35)