Clinical trial NCT02873689: Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heartburn
Gastroesophageal Reflux Disease
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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 7 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.

Eligibility criteria: Inclusion Criteria:

1. Participants identifying their main symptom as a burning feeling in the mid-epigastric area and/or chest area (that is, heartburn).
2. 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.
3. Must have episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the eDiary.

Exclusion Criteria:

1. 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.
2. Has a known history of Barrett's esophagus with dysplastic changes or any changes suspicious Barrett's seen during screening endoscopy.
3. Participant 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 (greater than \[\>\] 12 doses per month) of nonsteroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period and throughout the study.
4. 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).
5. 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.
6. Has erosive esophagitis (EE) as shown by endoscopy, during the Screening Period.
7. 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).
8. Has current or historical evidence of Zollinger-Ellison syndrome or a history of gastric acid hypersecretion.
9. Is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
10. 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.
11. Has a history of alcohol abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to Screening.
12. Participant with positive serology result of Helicobacter pylori (H. pylori) that needs eradication therapy during the study participation period as anticipated by the investigator.

Primary outcomes:
measure: Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment
timeFrame: Up to Week 4
Secondary outcomes:
measure: Percentage of Days Without Nighttime Heartburn During Treatment
timeFrame: Up to Week 4
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chong Qing
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chong Qing
city: Xia Men
country: China
facility: Zhongshan Hospital Xiamen University
state: Fu Jian
city: Nan Ning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guang XI
city: Hai Kou
country: China
facility: Affilicated Hospital of Guilin Medical University
state: Gui Lin
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Shi Yan
country: China
facility: Taihe Hospital
state: Hu Bei
city: Wuhan
country: China
facility: Central Hospital of Wuhan
state: Hu Bei
city: Wuhan
country: China
facility: Puai Hospital Of Wuhan City
state: Hu Bei
city: Chang Sha
country: China
facility: The Third Hospital of Changsha
state: Hu Nan
city: Nan Jing
country: China
facility: Zhongda Hospital Southeast
state: Jiang Su
city: Wu XI
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiang Su
city: Wu XI
country: China
facility: Wuxi people's hospital
state: Jiang Su
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Cheng Du
country: China
facility: West China Hospital,Sichuan University
state: Si Chuang
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: