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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1128-5977 | Registry Identifier | WHO | |
| 2012-001680-72 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexlansoprazole 30 mg | Experimental | Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole | Drug | Dexlansoprazole delayed-release capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda Global Research and Development Center, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28916953 | Derived | 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. |
| Label | URL |
|---|---|
| Dexilant Package Insert | View source |
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Adolescent participants (male or female), aged 12 to 17 years (inclusive) with symptomatic non-erosive gastrointestinal reflux disease were enrolled in 1 group and received dexlansoprazole 30 mg orally once daily for up to 4 weeks.
Participants took part in the study at 36 sites in the United States, Belgium, Hungary, Italy, Poland, Portugal, Brazil, and Mexico from 22 June 2012 to 21 January 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexlansoprazole 30 mg | Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| 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 |
| Toledo | Ohio | United States |
| Youngstown | Ohio | United States |
| Greenville | South Carolina | United States |
| Kingsport | Tennessee | United States |
| Fort 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 |
| Brussels | Belgium |
| Passo Fundo | Rio Grande do Sul | Brazil |
| Porto Alegre | Rio Grande do Sul | Brazil |
| Santo André | São Paulo | Brazil |
| São José do Rio Preto | São Paulo | Brazil |
| Debrecen | Hungary |
| Győr | Hungary |
| Miskolc | Hungary |
| Nyíregyháza | Hungary |
| Pécs | Hungary |
| Veszprém | Hungary |
| Bari | Bari | Italy |
| Messina | Messina | Italy |
| Roma | Roma | Italy |
| Mexico City | Mexico City | Mexico |
| Monterrey | Nuevo León | Mexico |
| Culiacán | Sinaloa | Mexico |
| Bydgoszcz | Poland |
| Krakow | Poland |
| Rzeszów | Poland |
| Szczecin | Poland |
| Torun | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Amadora | Portugal |
| Braga | Portugal |
| Coimbra | Portugal |
| Lisbon | Portugal |
| Porto | Portugal |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set: All participants who received at least 1 dose of study drug and had post-baseline data (and baseline data if applicable) for the appropriate efficacy variable.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexlansoprazole 30 mg | Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Smoking Classification | Number | participants |
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| H pylori Status | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set: All participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | 4 weeks |
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| 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. | Full analysis set: All participants who received at least 1 dose of study drug and had post-baseline data (and baseline data if applicable) for the efficacy variable. | Posted | Median | Full Range | Percentage of days | 4 weeks |
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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
At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexlansoprazole 30 mg | Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks. | 0 | 104 | 14 | 104 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Multiracial |
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| Not Collected |
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