Back to resultsEfficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis
Primary Purpose
Erosive Esophagitis
Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Dexlansoprazole
Lansoprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Esophagitis focused on measuring Drug therapy
Eligibility Criteria
Inclusion Criteria:
1. Has endoscopically confirmed EE as defined by the LA Classification Grading System (A-D).
Exclusion Criteria:
- Participant is required to take excluded medications, or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period.
- Has a hypersensitivity to any proton pump inhibitor (PPI) (including, but not limited to, lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole or ilaprazole), any component of dexlansoprazole, or antacid (example, magnesium trisilicate or similar antacid).
- Had a history of cancer, (except basal cell carcinoma of the skin), that has not been in remission for at least 5 years prior to Screening.
- Has a known history or any suspicious Barrett's esophagus with dysplastic changes seen during screening endoscopy.
- Developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days before the start of the Screening Visit (with the possible inclusion of those with gastric or duodenal erosion). The participant requires chronic use (>12 doses per month) of non steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period and throughout the study.
- Has comorbidities that could affect the esophagus (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal strictures); a history of radiotherapy or cryotherapy of the esophagus; and a history of corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki's ring).
- Has a history of surgical procedures that may affect the esophagus (example, fundoplication and mechanical dilatation for esophageal strictures) or a history of gastric or duodenal surgery other than endoscopic removal of benign polyps.
- Participant is known to have the acquired immunodeficiency syndrome (AIDS) or hepatitis, including hepatitis virus carriers (that is, hepatitis B surface antigen HBs-antigen (HBsAg) positive or hepatitis C virus (HCV)-antibody positive).
- Has current Zollinger-Ellison syndrome (gastric acid hyper secretion) or a history of gastric acid hypersecretion.
- Participant is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
- Has donated or lost >300 milliliter (mL) blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
- Has a history of alcohol or drug abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to Screening.
- The participant with positive serology result of Helicobacter pylori (H. pylori) that needs eradication therapy during the study participation period as anticipated by the investigator.
Sites / Locations
- Peking University First Hospital
- Peking Union Medical College Hospital
- Chongqing Three Gorges Central Hospital
- Zhongshan Hospital Xiamen University
- The People's Hospital of Guangxi Zhuang Autonomous Region
- Affilicated Hospital of Guilin Medical University
- Hebei General Hospital
- Taihe Hospital
- Central Hospital of Wuhan
- Puai Hospital Of Wuhan City
- The Third Hospital of Changsha
- Zhongda Hospital Southeast
- Affiliated Hospital of Jiangsu University
- Wuxi people's hospital
- The First Hospital of Jilin University
- Shengjing Hospital of China Medical University
- Binzhou Medical University Hospital
- Jinan Central Hospital
- Liaocheng Hospital
- The Affiliated Hospital of Qingdao University
- Renji Hospital Shanghai Jiaotong University School of Medicine
- The First Hospital of Shanxi Medical University
- The Second Hospital of Shanxi Medical University
- West China Hospital,Sichuan University
- Tianjin People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Healing Period: Dexlansoprazole 60 mg
Healing Period: Lansoprazole 30 mg
Maintenance Period: Dexlansprazole 30 mg
Maintenance Period: Placebo
Arm Description
Dexlansoprazole 60 milligram (mg), delayed-release capsules, orally, once daily for up to 8 weeks in the Healing Period.
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02873702
Brief Title
Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis
Official Title
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole (60 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis, and Maintenance of Healing in Subjects With Healed Erosive Esophagitis With Dexlansoprazole (30 mg QD) and Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Compound is not expected to change the current treatment practice or fill significant clinical need for patients in China over currently available EE agents.
Study Start Date
December 21, 2016 (Actual)
Primary Completion Date
October 16, 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of dexlansoprazole compared to lansoprazole in healing erosive esophagitis (EE) in Chinese participants.
Detailed Description
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):
Dexlansoprazole 60 mg
Lansoprazole 30 mg
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:
Dexlansoprazole 30 mg
Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis
Keywords
Drug therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healing Period: Dexlansoprazole 60 mg
Arm Type
Experimental
Arm Description
Dexlansoprazole 60 milligram (mg), delayed-release capsules, orally, once daily for up to 8 weeks in the Healing Period.
Arm Title
Healing Period: Lansoprazole 30 mg
Arm Type
Experimental
Arm Description
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
Arm Title
Maintenance Period: Dexlansprazole 30 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Maintenance Period: Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole
Intervention Description
Dexlansoprazole delayed-release capsules.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
Lansoprazole capsules.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dexlansoprazole placebo-matching capsules.
Primary Outcome Measure Information:
Title
Healing Period: Percentage of Participants With Complete Healing of EE at Week 8
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6
Description
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.
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Has endoscopically confirmed EE as defined by the LA Classification Grading System (A-D).
Exclusion Criteria:
Participant is required to take excluded medications, or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period.
Has a hypersensitivity to any proton pump inhibitor (PPI) (including, but not limited to, lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole or ilaprazole), any component of dexlansoprazole, or antacid (example, magnesium trisilicate or similar antacid).
Had a history of cancer, (except basal cell carcinoma of the skin), that has not been in remission for at least 5 years prior to Screening.
Has a known history or any suspicious Barrett's esophagus with dysplastic changes seen during screening endoscopy.
Developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days before the start of the Screening Visit (with the possible inclusion of those with gastric or duodenal erosion). The participant requires chronic use (>12 doses per month) of non steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period and throughout the study.
Has comorbidities that could affect the esophagus (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal strictures); a history of radiotherapy or cryotherapy of the esophagus; and a history of corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki's ring).
Has a history of surgical procedures that may affect the esophagus (example, fundoplication and mechanical dilatation for esophageal strictures) or a history of gastric or duodenal surgery other than endoscopic removal of benign polyps.
Participant is known to have the acquired immunodeficiency syndrome (AIDS) or hepatitis, including hepatitis virus carriers (that is, hepatitis B surface antigen HBs-antigen (HBsAg) positive or hepatitis C virus (HCV)-antibody positive).
Has current Zollinger-Ellison syndrome (gastric acid hyper secretion) or a history of gastric acid hypersecretion.
Participant is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
Has donated or lost >300 milliliter (mL) blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
Has a history of alcohol or drug abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to Screening.
The participant with positive serology result of Helicobacter pylori (H. pylori) that needs eradication therapy during the study participation period as anticipated by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chongqing Three Gorges Central Hospital
City
Chong Qing
State/Province
Chong Qing
ZIP/Postal Code
404100
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xia Men
State/Province
Fu Jian
ZIP/Postal Code
361004
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nan Ning
State/Province
Guang XI
ZIP/Postal Code
530022
Country
China
Facility Name
Affilicated Hospital of Guilin Medical University
City
Hai Kou
State/Province
Gui Lin
ZIP/Postal Code
570100
Country
China
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
Taihe Hospital
City
Shi Yan
State/Province
Hu Bei
ZIP/Postal Code
442000
Country
China
Facility Name
Central Hospital of Wuhan
City
Wuhan
State/Province
Hu Bei
ZIP/Postal Code
430000
Country
China
Facility Name
Puai Hospital Of Wuhan City
City
Wuhan
State/Province
Hu Bei
ZIP/Postal Code
430000
Country
China
Facility Name
The Third Hospital of Changsha
City
Chang Sha
State/Province
Hu Nan
ZIP/Postal Code
410015
Country
China
Facility Name
Zhongda Hospital Southeast
City
Nan Jing
State/Province
Jiang Su
ZIP/Postal Code
210009
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Wu XI
State/Province
Jiang Su
ZIP/Postal Code
212001
Country
China
Facility Name
Wuxi people's hospital
City
Wu XI
State/Province
Jiang Su
ZIP/Postal Code
214023
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Binzhou Medical University Hospital
City
Binzhou
State/Province
Shandong
ZIP/Postal Code
256603
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Liaocheng Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20001
Country
China
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
The Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
West China Hospital,Sichuan University
City
Cheng Du
State/Province
Si Chuang
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300121
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Learn more about this trial
Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis
We'll reach out to this number within 24 hrs