Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents

NCT01642615 | Completed Phase 2 Results

• 3 other identifiers: TAK-390MR_207U1111-1128-61172012-001681-15
• Study Type: interventional
• Target: 63
• Locations: 8 countries
• Sites: 60

Brief Summary

The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.

Conditions

Gastroesophageal Reflux Disease; Erosive Esophagitis

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period

  An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.

  8 weeks

• Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period

  An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.

  From Week 8 to Week 24

Secondary Outcomes (4)

• Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8

  8 weeks

• Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24

  From Week 8 to Week 24

• Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment

  8 weeks

• Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24

  Weeks 8 to 24

Study Arms (3)

Healing Phase: Dexlansoprazole 60 mg

EXPERIMENTAL

Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.

Drug: Dexlansoprazole

Maintenance Phase: Dexlansoprazole 30 mg

EXPERIMENTAL

Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.

Drug: Dexlansoprazole

Maintenance Phase: Placebo

EXPERIMENTAL

Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.

Drug: Placebo

Interventions

Dexlansoprazole DRUG

Dexlansoprazole capsules

Also known as: Dexilant

Healing Phase: Dexlansoprazole 60 mg

Placebo DRUG

Dexlansoprazole placebo-matching capsules

Maintenance Phase: Placebo

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 Gastroesophageal Reflux Disease (GERD) for at least 3 months prior to Screening (signed informed consent form 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.(Note: if an endoscopy done within 1 week of signing informed consent and assent is used to confirm diagnosis of EE, the subject does not need to meet this criterion).
• The participant has endoscopic evidence of EE (LA Grade A-D) based on 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, 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 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 participant tests positive for tissue transglutaminase (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 proton pump inhibitor (PPI) within 1 week (7 days) prior to the Screening Visit.
• Participant tests positive for H. pylori.
• 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 human immunodeficiency virus (HIV) positive.

Sponsors & Collaborators

• Takeda: lead

Study Sites (60)

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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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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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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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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 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
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 27, 2015
• Results First Posted: May 27, 2015

Record last verified: 2015-05

Locations

PT (5); BR (4); IT (3); BE (1); PL (7); HU (5); US (32); ME (3)