Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

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)

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).

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease; Heartburn
• Intervention / Treatment: Drug: Placebo; Drug: Dexlansoprazole

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.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100032
      • Peking University First Hospital
  • Chong Qing
    • Chong Qing, Chong Qing, China, 404100
      • Chongqing Three Gorges Central Hospital
  • Fu Jian
    • Xia Men, Fu Jian, China, 361004
      • Zhongshan Hospital Xiamen University
  • Guang XI
    • Nan Ning, Guang XI, China, 530022
      • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Gui Lin
    • Hai Kou, Gui Lin, China, 570100
      • Affilicated Hospital of Guilin Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050051
      • Hebei General Hospital
  • Hu Bei
    • Shi Yan, Hu Bei, China, 442000
      • Taihe Hospital
    • Wuhan, Hu Bei, China, 430000
      • Central Hospital of Wuhan
    • Wuhan, Hu Bei, China, 430000
      • Puai Hospital Of Wuhan City
  • Hu Nan
    • Chang Sha, Hu Nan, China, 410015
      • The Third Hospital of Changsha
  • Jiang Su
    • Nan Jing, Jiang Su, China, 210009
      • Zhongda Hospital Southeast
    • Wu XI, Jiang Su, China, 212001
      • Affiliated Hospital of Jiangsu University
    • Wu XI, Jiang Su, China, 214023
      • Wuxi People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130000
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
  • Shandong
    • Binzhou, Shandong, China, 256603
      • Binzhou Medical University Hospital
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
    • Liaocheng, Shandong, China, 252000
      • Liaocheng Hospital
    • Qingdao, Shandong, China, 266003
      • The Affiliated Hospital of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China, 20001
      • Renji Hospital Shanghai Jiaotong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • The First Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China, 030001
      • The Second Hospital of Shanxi Medical University
  • Si Chuang
    • Cheng Du, Si Chuang, China, 610041
      • West China Hospital,Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300121
      • Tianjin People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexlansoprazole 30 mg; Dexlansoprazole 30 mg, delayed-release capsule, orally, once daily for up to 4 weeks.	Drug: Dexlansoprazole; Dexlansoprazole delayed-release capsule
Experimental: Placebo; Dexlansoprazole placebo-matching capsules, orally, once daily for up to 4 weeks.	Drug: Placebo; Dexlansoprazole placebo-matching capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2016
• Primary Completion (Actual): March 14, 2018
• Study Completion (Actual): April 19, 2018

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Heartburn; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: TAK-390MR_302; U1111-1171-1002 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.