Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients
A Phase 3 Double-blind Study to Evaluate the Efficacy and Safety of Dexlansoprazole (30 mg QD) Compared to Placebo on Heartburn Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)
2 other identifiers
interventional
217
1 country
25
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 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 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2018
CompletedResults Posted
Study results publicly available
July 5, 2019
CompletedJuly 5, 2019
July 1, 2019
1.2 years
August 17, 2016
March 12, 2019
July 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Percentage of Days Without Nighttime Heartburn During Treatment
Up to Week 4
Study Arms (2)
Dexlansoprazole 30 mg
EXPERIMENTALDexlansoprazole 30 mg, delayed-release capsule, orally, once daily for up to 4 weeks.
Placebo
EXPERIMENTALDexlansoprazole placebo-matching capsules, orally, once daily for up to 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participants identifying their main symptom as a burning feeling in the mid-epigastric area and/or chest area (that is, heartburn).
- Must have a history of symptomatic GERD for 6 months or longer prior to Screening with GERD symptoms that were responsive to acid-suppressive therapy.
- Must have episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the eDiary.
You may not qualify if:
- Has 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 of Barrett's esophagus with dysplastic changes or any changes suspicious Barrett's 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.
- Has erosive esophagitis (EE) as shown by endoscopy, during the Screening Period.
- Is known to have 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 or historical evidence of Zollinger-Ellison syndrome or a history of gastric acid hypersecretion.
- 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 abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to Screening.
- 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
Conditions
Interventions
Condition Hierarchy (Ancestors)
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 27, 2016
Primary Completion
March 14, 2018
Study Completion
April 19, 2018
Last Updated
July 5, 2019
Results First Posted
July 5, 2019
Record last verified: 2019-07
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.