Study 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.
Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis
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
2 other identifiers
interventional
37
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2016
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedStudy Start
First participant enrolled
December 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2017
CompletedResults Posted
Study results publicly available
February 22, 2019
CompletedFebruary 22, 2019
October 1, 2018
10 months
August 17, 2016
October 11, 2018
October 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6
Month 6
Study Arms (4)
Healing Period: Dexlansoprazole 60 mg
EXPERIMENTALDexlansoprazole 60 milligram (mg), delayed-release capsules, orally, once daily for up to 8 weeks in the Healing Period.
Healing Period: Lansoprazole 30 mg
EXPERIMENTALLansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
Maintenance Period: Dexlansprazole 30 mg
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Dexlansoprazole delayed-release capsules.
Eligibility Criteria
You may qualify if:
- \. Has endoscopically confirmed EE as defined by the LA Classification Grading System (A-D).
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (25)
Peking University First Hospital
Beijing, Beijing Municipality, 100032, China
Peking Union Medical College Hospital
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
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
August 17, 2016
First Posted
August 19, 2016
Study Start
December 21, 2016
Primary Completion
October 16, 2017
Study Completion
November 6, 2017
Last Updated
February 22, 2019
Results First Posted
February 22, 2019
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will share
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.