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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1171-1002 | Registry Identifier | WHO |
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The purpose of this study is to determine the efficacy and safety of dexlansoprazole compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat heartburn in people who have non-erosive gastroesophageal reflux disease (GERD). This study will look at heartburn relief in people who take dexlansoprazole.
The study will enroll approximately 200 participants. Participants will be randomly assigned to one of the two treatment groups with 1:1 ratio -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
All participants will be asked to take one capsule at the same time each day throughout the study, and will be asked to record any time they have heartburn symptoms in a diary.
This multi-center trial will be conducted in China. The overall time to participate in this study is up to 7 weeks. Participants will make 4 visits to the clinic, and will be contacted by telephone 5 to 10 days after the last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexlansoprazole 30 mg | Experimental | Dexlansoprazole 30 mg, delayed-release capsule, orally, once daily for up to 4 weeks. |
|
| Placebo | Experimental | Dexlansoprazole placebo-matching 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 capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment | The percentage of days with neither daytime nor nighttime heartburn was equal to (=) (the days that were heartburn-free during the treatment period) / (total number of days for which either a daytime or nighttime result was marked during treatment period)*100 percent (%). | Up to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days Without Nighttime Heartburn During Treatment | The percentage of days without nighttime heartburn was = (the days that were heartburn-free during the treatment period) / (total number of days for which nighttime result was marked during treatment period)*100%. | Up to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100032 | China | ||
| Peking Union Medical College Hospital |
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| Label | URL |
|---|---|
| Dexlansoprazole Package Insert | View source |
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Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Participants with diagnosis of symptomatic nonerosive gastroesophageal reflux disease (GERD) were enrolled in 1 of the 2 treatment groups: to receive dexlansoprazole 30 mg or placebo.
Participants took part in the study at 20 investigative sites in China from 27 December 2016 to 19 April 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks. |
| FG001 | Dexlansoprazole 30 mg | Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2018 | Mar 12, 2019 |
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| Placebo |
| Drug |
Dexlansoprazole placebo-matching capsules |
|
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Chongqing Three Gorges Central Hospital | Chongqing | Chong Qing | 404100 | China |
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | 361004 | China |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530022 | China |
| Affilicated Hospital of Guilin Medical University | Haikou | Gui Lin | 570100 | China |
| Hebei General Hospital | Shijiazhuang | Hebei | 050051 | China |
| Taihe Hospital | Shiyan | Hubei | 442000 | China |
| Central Hospital of Wuhan | Wuhan | Hubei | 430000 | China |
| Puai Hospital Of Wuhan City | Wuhan | Hubei | 430000 | China |
| The Third Hospital of Changsha | Changsha | Hunan | 410015 | China |
| Zhongda Hospital Southeast | Nanjing | Jiangsu | 210009 | China |
| Affiliated Hospital of Jiangsu University | Wuxi | Jiangsu | 212001 | China |
| Wuxi people's hospital | Wuxi | Jiangsu | 214023 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| Binzhou Medical University Hospital | Binzhou | Shandong | 256603 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Liaocheng Hospital | Liaocheng | Shandong | 252000 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266003 | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 20001 | China |
| The First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| West China Hospital,Sichuan University | Chengdu | Si Chuang | 610041 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300121 | China |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set included all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks. |
| BG001 | Dexlansoprazole 30 mg | Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
| |||||||||||||||
| Helicobacter pylori status | Count of Participants | Participants |
| ||||||||||||||||
| Number of days with day and nighttime heartburn between study days -8 to -2 | Mean | Standard Deviation | days |
| |||||||||||||||
| Number of days with nighttime heartburn between study days -8 to -2 | The safety analysis set where participants for nighttime heartburn at baseline were available. | Mean | Standard Deviation | days |
| ||||||||||||||
| Number of days with daytime heartburn between study days -8 to -2 | The safety analysis set where participants for daytime heartburn at baseline were available. | Mean | Standard Deviation | days |
| ||||||||||||||
| Severity of GERD symptoms: heartburn | Count of Participants | Participants |
| ||||||||||||||||
| Severity of GERD symptoms: acid regurgitation | Count of Participants | Participants |
| ||||||||||||||||
| Severity of GERD symptoms: dysphagia | Count of Participants | Participants |
| ||||||||||||||||
| Severity of GERD symptoms: belching | Count of Participants | Participants |
| ||||||||||||||||
| Severity of GERD symptoms: epigastric pain | Count of Participants | Participants |
| ||||||||||||||||
| Number of days with rescue medication use | Mean | Standard Deviation | days |
|
| 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 | Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment | The percentage of days with neither daytime nor nighttime heartburn was equal to (=) (the days that were heartburn-free during the treatment period) / (total number of days for which either a daytime or nighttime result was marked during treatment period)*100 percent (%). | Full analysis set included all randomized participants who received at least 1 dose of study drug and had post-baseline (post Day-1) data for the appropriate efficacy variables. | Posted | Median | Full Range | percentage of days | Up to Week 4 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Days Without Nighttime Heartburn During Treatment | The percentage of days without nighttime heartburn was = (the days that were heartburn-free during the treatment period) / (total number of days for which nighttime result was marked during treatment period)*100%. | Full analysis set included all randomized participants who received at least 1 dose of study drug and had post-baseline (post Day-1) data for the appropriate efficacy variables. | Posted | Median | Full Range | percentage of days | Up to Week 4 |
|
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Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug (approximately Week 8).
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 | Placebo | Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks. | 0 | 108 | 0 | 108 | 15 | 108 |
| EG001 | Dexlansoprazole 30 mg | Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks. | 0 | 107 | 1 | 107 | 9 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Animal scratch | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | 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 | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 20, 2017 | Mar 12, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D006356 | Heartburn |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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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| Negative |
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| Mild |
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| Moderate |
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| Severe |
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| Very Severe |
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| Mild |
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| Moderate |
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| Severe |
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| Very Severe |
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| Mild |
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| Moderate |
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| Severe |
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| Very Severe |
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| Mild |
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| Moderate |
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| Severe |
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| Very Severe |
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| Mild |
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| Moderate |
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| Severe |
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| Very Severe |
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