Clinical trial NCT02873702: Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole (60 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis, and Maintenance of Healing in Subjects With Healed Erosive Esophagitis With Dexlansoprazole (30 mg QD) and Placebo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Erosive Esophagitis
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 37
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 of dexlansoprazole compared to lansoprazole in healing erosive esophagitis (EE) in Chinese participants.

Detailed description: The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat people who have EE. This study will look at erosive esophageal healing in people who take dexlansoprazole.

The study will enroll approximately 450 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 60 mg
* Lansoprazole 30 mg

After 8 weeks of treatment, participants will be evaluated to assess esophageal healing. If the EE is healed participants will be randomly assigned to one of two different treatment groups with 1:1 ratio:

* 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.

This multi-center trial will be conducted in China. The overall time to participate in this study is up to 39 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

1. Has endoscopically confirmed EE as defined by the LA Classification Grading System (A-D).

Exclusion Criteria:

1. Participant is required to take excluded medications, or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period.
2. Has a hypersensitivity to any proton pump inhibitor (PPI) (including, but not limited to, lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole or ilaprazole), any component of dexlansoprazole, or antacid (example, magnesium trisilicate or similar antacid).
3. Had 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.
4. Has a known history or any suspicious Barrett's esophagus with dysplastic changes seen during screening endoscopy.
5. 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 (\>12 doses per month) of non steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period and throughout the study.
6. 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).
7. 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.
8. Participant is known to have the 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).
9. Has current Zollinger-Ellison syndrome (gastric acid hyper secretion) or a history of gastric acid hypersecretion.
10. Participant is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
11. 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.
12. Has a history of alcohol or drug abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to Screening.
13. The 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: Healing Period: Percentage of Participants With Complete Healing of EE at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6
timeFrame: Month 6
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: