Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

Gastroesophageal Reflux Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873689
• Other study ID #: TAK-390MR_302
• Secondary ID: U1111-1171-1002
• Status: Completed
• Phase: Phase 3
• Start date: December 27, 2016
• Est. completion date: April 19, 2018

Study information

• Verified date: July 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: April 19, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Heartburn

Intervention

Drug:
• Dexlansoprazole
Dexlansoprazole delayed-release capsule
• Placebo
Dexlansoprazole placebo-matching capsules

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	The Third Hospital of Changsha	Chang Sha	Hu Nan
China	The First Hospital of Jilin University	Changchun	Jilin
China	West China Hospital,Sichuan University	Cheng Du	Si Chuang
China	Chongqing Three Gorges Central Hospital	Chong Qing	Chong Qing
China	Affilicated Hospital of Guilin Medical University	Hai Kou	Gui Lin
China	Jinan Central Hospital	Jinan	Shandong
China	Liaocheng Hospital	Liaocheng	Shandong
China	Zhongda Hospital Southeast	Nan Jing	Jiang Su
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nan Ning	Guang XI
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Renji Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Taihe Hospital	Shi Yan	Hu Bei
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin People's Hospital	Tianjin	Tianjin
China	Affiliated Hospital of Jiangsu University	Wu XI	Jiang Su
China	Wuxi people's hospital	Wu XI	Jiang Su
China	Central Hospital of Wuhan	Wuhan	Hu Bei
China	Puai Hospital Of Wuhan City	Wuhan	Hu Bei
China	Zhongshan Hospital Xiamen University	Xia Men	Fu Jian

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Days Without Nighttime Heartburn During Treatment	The percentage of days without nighttime heartburn was = (the days that were heartburn-free during the treatment period) / (total number of days for which nighttime result was marked during treatment period)*100%.	Up to Week 4

External Links

•   Dexlansoprazole Package Insert