Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

NCT ID: NCT02873689

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-27
• Study Completion Date: 2018-04-19

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.

Conditions

Heartburn; Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dexlansoprazole 30 mg

Dexlansoprazole 30 mg, delayed-release capsule, orally, once daily for up to 4 weeks.

Group Type: EXPERIMENTAL

Dexlansoprazole

Intervention Type: DRUG

Dexlansoprazole delayed-release capsule

Placebo

Dexlansoprazole placebo-matching capsules, orally, once daily for up to 4 weeks.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Dexlansoprazole placebo-matching capsules

Interventions

Dexlansoprazole

Dexlansoprazole delayed-release capsule

Intervention Type: DRUG

Placebo

Dexlansoprazole placebo-matching capsules

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Chongqing Three Gorges Central Hospital

Chongqing, Chong Qing, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Affilicated Hospital of Guilin Medical University

Haikou, Gui Lin, China

Hebei General Hospital

Shijiazhuang, Hebei, China

Taihe Hospital

Shiyan, Hubei, China

Central Hospital of Wuhan

Wuhan, Hubei, China

Puai Hospital Of Wuhan City

Wuhan, Hubei, China

The Third Hospital of Changsha

Changsha, Hunan, China

Zhongda Hospital Southeast

Nanjing, Jiangsu, China

Affiliated Hospital of Jiangsu University

Wuxi, Jiangsu, China

Wuxi people's hospital

Wuxi, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Liaocheng Hospital

Liaocheng, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

West China Hospital,Sichuan University

Chengdu, Si Chuang, China

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

http://general.takedapharm.com/content/file/pi.pdf?applicationcode=9efb34b3-fb69-4190-a2be-a90b8cb94e25&filetypecode=DEXILANTPI

Dexlansoprazole Package Insert

Other Identifiers

U1111-1171-1002

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-390MR_302

Identifier Type: -

Identifier Source: org_study_id