Phase
Condition
Esophageal Disorders
Gastroesophageal Reflux Disease (Gerd)
Heartburn (Pediatric)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants identifying their main symptom as a burning feeling in the mid-epigastricarea and/or chest area (that is, heartburn).
Must have a history of symptomatic GERD for 6 months or longer prior to Screening withGERD 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 -1as recorded in the eDiary.
Exclusion
Exclusion Criteria:
Has a history of cancer (except basal cell carcinoma of the skin), that has not beenin remission for at least 5 years prior to Screening.
Has a known history of Barrett's esophagus with dysplastic changes or any changessuspicious Barrett's seen during screening endoscopy.
Participant developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosaldefect 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 ofthose with gastric or duodenal erosion). The participant requires chronic use (greaterthan [>] 12 doses per month) of nonsteroidal anti-inflammatory drugs (NSAIDs)including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Periodand throughout the study.
Has comorbidities that could affect the esophagus (eosinophilic esophagitis,esophageal varices, scleroderma, viral or fungal infection, esophageal strictures); ahistory of radiotherapy or cryotherapy of the esophagus; and a history of corrosive orphysiochemical injury (with the possible inclusion in the study of those withSchatzki's ring).
Has a history of surgical procedures that may affect the esophagus (example,fundoplication and mechanical dilatation for esophageal strictures) or a history ofgastric 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, includinghepatitis 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 ofgastric acid hypersecretion.
Is scheduled for surgery that requires hospitalization or requires surgical treatmentduring his/her participation in the study.
Has donated or lost >300 milliliter (mL) blood volume, undergone plasmapheresis, orhas had a transfusion of any blood product within 90 days prior to the first dose ofstudy drug.
Has a history of alcohol abuse (defined as any illicit drug use), or drug addiction inthe 12 months prior to Screening.
Participant with positive serology result of Helicobacter pylori (H. pylori) thatneeds eradication therapy during the study participation period as anticipated by theinvestigator.
Study Design
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing 100730
ChinaSite Not Available
Peking University First Hospital
Beijing, Beijing 100032
ChinaSite Not Available
Chongqing Three Gorges Central Hospital
Chong Qing, Chong Qing 404100
ChinaSite Not Available
Zhongshan Hospital Xiamen University
Xia Men, Fu Jian 361004
ChinaSite Not Available
The People's Hospital of Guangxi Zhuang Autonomous Region
Nan Ning, Guang XI 530022
ChinaSite Not Available
Affilicated Hospital of Guilin Medical University
Hai Kou, Gui Lin 570100
ChinaSite Not Available
Hebei General Hospital
Shijiazhuang, Hebei 050051
ChinaSite Not Available
Taihe Hospital
Shi Yan, Hu Bei 442000
ChinaSite Not Available
Central Hospital of Wuhan
Wuhan, Hu Bei 430000
ChinaSite Not Available
Puai Hospital Of Wuhan City
Wuhan, Hu Bei 430000
ChinaSite Not Available
The Third Hospital of Changsha
Chang Sha, Hu Nan 410015
ChinaSite Not Available
empty
Shiyan, Hubei
ChinaSite Not Available
Zhongda Hospital Southeast
Nan Jing, Jiang Su 210009
ChinaSite Not Available
Affiliated Hospital of Jiangsu University
Wu XI, Jiang Su 212001
ChinaSite Not Available
Wuxi people's hospital
Wu XI, Jiang Su 214023
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130000
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang, Liaoning 110004
ChinaSite Not Available
Binzhou Medical University Hospital
Binzhou, Shandong 256603
ChinaSite Not Available
Jinan Central Hospital
Jinan, Shandong 250013
ChinaSite Not Available
Liaocheng Hospital
Liaocheng, Shandong 252000
ChinaSite Not Available
The Affiliated Hospital of Qingdao University
Qingdao, Shandong 266003
ChinaSite Not Available
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 20001
ChinaSite Not Available
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi 030001
ChinaSite Not Available
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi 030001
ChinaSite Not Available
West China Hospital,Sichuan University
Cheng Du, Si Chuang 610041
ChinaSite Not Available
Tianjin People's Hospital
Tianjin, Tianjin 300121
ChinaSite Not Available

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