Last updated on June 2017

Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients


Brief description of study

The purpose of this study is to determine the efficacy 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).

Detailed Study Description

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): - 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, 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 11 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.

Clinical Study Identifier: NCT02873689

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Peking University First Hospital
Beijing, China
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Peking Union Medical College Hospital
Beijing, China
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Chongqing Three Gorges Central Hospital
Chong Qing, China
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Zhongshan Hospital Xiamen University
Xia Men, China
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The People's Hospital of Guangxi Zhuang Autonomous Region
Nan Ning, China
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Affilicated Hospital of Guilin Medical University
Hai Kou, China
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Hebei General Hospital
Shijiazhuang, China
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Central Hospital of Wuhan
Wuhan, China
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Puai Hospital Of Wuhan City
Wuhan, China
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The Third Hospital of Changsha
Chang Sha, China
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Zhongda Hospital Southeast
Nan Jing, China
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Affiliated Hospital of Jiangsu University
Wu Xi, China
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Wuxi people's hospital
Wu XI, China
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The First Hospital of Jilin University
Changchun, China
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Shengjing Hospital of China Medical University
Shenyang, China
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Binzhou Medical University Hospital
Binzhou, China
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Jinan Central Hospital
Jinan, China
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Liaocheng Hospital
Liaocheng, China
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The Affiliated Hospital of Qingdao University
Qingdao, China
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Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
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The First Hospital of Shanxi Medical University
Taiyuan, China
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The Second Hospital of Shanxi Medical University
Taiyuan, China
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West China Hospital,Sichuan University
Cheng Du, China
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Tianjin People's Hospital
Tianjin, China
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