Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

Phase 3

Completed

• Conditions: Heartburn; Gastroesophageal Reflux Disease
• Interventions: Drug: Placebo; Drug: Dexlansoprazole

• Registration Number: NCT02873689
• Lead Sponsor: Takeda

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.

Study Timeline

• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-19
• Study Start: 2016-12-27
• Primary Completion: 2018-03-14
• Study Completion: 2018-04-19
• Results First Submitted: 2019-03-12
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-03
• Last Update Submitted: 2019-07-03
• Results First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dexlansoprazole placebo-matching capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole 30 mg	Dexlansoprazole	Dexlansoprazole 30 mg, delayed-release capsule, orally, once daily for up to 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment	Up to Week 4	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 (%).

Secondary Outcome Measures

Name	Time	Method
Percentage of Days Without Nighttime Heartburn During Treatment	Up to Week 4	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%.

Trial Locations

Locations (25)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

The People's Hospital of Guangxi Zhuang Autonomous Region; 🇨🇳 Nan Ning, Guang XI, China

Affilicated Hospital of Guilin Medical University; 🇨🇳 Hai Kou, Gui Lin, China

Central Hospital of Wuhan; 🇨🇳 Wuhan, Hu Bei, China

The Third Hospital of Changsha; 🇨🇳 Chang Sha, Hu Nan, China

Zhongda Hospital Southeast; 🇨🇳 Nan Jing, Jiang Su, China

Affiliated Hospital of Jiangsu University; 🇨🇳 Wu XI, Jiang Su, China

Wuxi people's hospital; 🇨🇳 Wu XI, Jiang Su, China

Liaocheng Hospital; 🇨🇳 Liaocheng, Shandong, China

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

West China Hospital,Sichuan University; 🇨🇳 Cheng Du, Si Chuang, China

Tianjin People's Hospital; 🇨🇳 Tianjin, Tianjin, China

Chongqing Three Gorges Central Hospital; 🇨🇳 Chong Qing, Chong Qing, China

Zhongshan Hospital Xiamen University; 🇨🇳 Xia Men, Fu Jian, China

Hebei General Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Taihe Hospital; 🇨🇳 Shi Yan, Hu Bei, China

Puai Hospital Of Wuhan City; 🇨🇳 Wuhan, Hu Bei, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Binzhou Medical University Hospital; 🇨🇳 Binzhou, Shandong, China

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China

The First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

The Second Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

Renji Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China