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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1142-0320 | Registry Identifier | WHO |
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Compound is not expected to change the current treatment practice or fill significant clinical need for patients in China over currently available EE agents.
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The purpose of this study is to determine the efficacy of dexlansoprazole compared to lansoprazole in healing erosive esophagitis (EE) in Chinese participants.
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat people who have EE. This study will look at erosive esophageal healing in people who take dexlansoprazole.
The study will enroll approximately 450 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):
After 8 weeks of treatment, participants will be evaluated to assess esophageal healing. If the EE is healed participants will be randomly assigned to one of two different treatment groups with 1:1 ratio:
All participants will be asked to take one capsule at the same time each day throughout the study.
This multi-center trial will be conducted in China. The overall time to participate in this study is up to 39 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healing Period: Dexlansoprazole 60 mg | Experimental | Dexlansoprazole 60 milligram (mg), delayed-release capsules, orally, once daily for up to 8 weeks in the Healing Period. |
|
| Healing Period: Lansoprazole 30 mg | Experimental | Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period. |
|
| Maintenance Period: Dexlansprazole 30 mg | Experimental | Participants who will be healed at Week 8 will be randomized to receive dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for up to 6 months in the Maintenance period. |
|
| Maintenance Period: Placebo | Experimental | Participants who will be healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 6 months in the Maintenance period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole | Drug | Dexlansoprazole delayed-release capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing Period: Percentage of Participants With Complete Healing of EE at Week 8 | Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the Los Angeles (LA) classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 millimeter [mm] that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break greater than [>] 5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75 percent (%) of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6 | Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the LA classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 mm that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break >5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75% of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O. |
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Inclusion Criteria:
1. Has endoscopically confirmed EE as defined by the LA Classification Grading System (A-D).
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 erosive esophagitis (EE) were enrolled to receive: lansoprazole 30 milligram (mg) or dexlansoprazole 60 mg in Healing Period and dexlansoprazole 30 mg or Placebo in Maintenance Period. Study was terminated since compound was not expected to provide sufficient additional benefit to participants over currently available therapies.
Participants took part in the study at 8 investigative sites in China from 21 December 2016 to 06 November 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healing Period: Lansoprazole 30 mg | Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period. |
| FG001 | Healing Period: Dexlansoprazole 60 mg | Dexlansoprazole 60 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Healing Period (up to Week 8) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2017 | Oct 11, 2018 |
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| Lansoprazole | Drug | Lansoprazole capsules. |
|
| Placebo | Drug | Dexlansoprazole placebo-matching capsules. |
|
| Month 6 |
| 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 |
| FG002 | Maintenance Period: Placebo | Dexlansoprazole placebo-matching capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period. |
| FG003 | Maintenance Period: Dexlansoprazole 30 mg | Dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period. |
| COMPLETED |
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| NOT COMPLETED |
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| Maintenance Period (up to Month 6) |
|
|
The full analysis set for the healing period (FAS-H) included all randomized participants who had documented EE at screening and had received at least 1 dose of study drug during the first 8 weeks of treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Healing Period: Lansoprazole 30 mg | Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period. |
| BG001 | Healing Period: Dexlansoprazole 60 mg | Dexlansoprazole 60 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period. |
| 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 |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Baseline Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
| |||||||||||||||
| BMI Categories | Count of Participants | Participants |
|
| 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 | Healing Period: Percentage of Participants With Complete Healing of EE at Week 8 | Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the Los Angeles (LA) classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 millimeter [mm] that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break greater than [>] 5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75 percent (%) of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O. | The FAS-H included all randomized participants who had documented EE at screening and had received at least 1 dose of study drug during the first 8 weeks of treatment. | Posted | Number | percentage of participants | Week 8 |
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| Secondary | Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6 | Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the LA classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 mm that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break >5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75% of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O. | The full analysis set for the maintenance period (FAS-M) included all participants with healed EE by week 8 who were randomized and received at least 1 dose of study drug during 6 months of maintenance treatment. | Posted | Number | percentage of participants | Month 6 |
|
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 5 to 10 days (Day 190) after the last dose of double-blind 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 | Healing Period: Lansoprazole 30 mg | Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period. | 0 | 20 | 0 | 20 | 15 | 20 |
| EG001 | Healing Period: Dexlansoprazole 60 mg | Dexlansoprazole 60 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period. | 0 | 17 | 0 | 17 | 7 | 17 |
| EG002 | Maintenance Period: Placebo | Dexlansoprazole placebo-matching capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG003 | Maintenance Period: Dexlansoprazole 30 mg | Dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for up to 6 months in the Maintenance period. Participants who were healed at Week 8 entered the Maintenance Period. | 0 | 8 | 0 | 8 | 5 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Laryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2018 | Oct 11, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| 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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| Relapse of EE |
|
| Withdrawal by Subject |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 25 to <30 kg/m^2 |
|
| Greater than or equal to (>=) 30 kg/m^2 |
|
|
|