Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis
NCT ID: NCT02873702
Last Updated: 2019-02-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
37 participants
INTERVENTIONAL
2016-12-21
2017-11-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Healing Period: Dexlansoprazole 60 mg
Dexlansoprazole 60 milligram (mg), delayed-release capsules, orally, once daily for up to 8 weeks in the Healing Period.
Dexlansoprazole
Dexlansoprazole delayed-release capsules.
Healing Period: Lansoprazole 30 mg
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
Lansoprazole
Lansoprazole capsules.
Maintenance Period: Dexlansprazole 30 mg
Participants who will be healed at Week 8 will be randomized to receive dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for up to 6 months in the Maintenance period.
Dexlansoprazole
Dexlansoprazole delayed-release capsules.
Maintenance Period: Placebo
Participants who will be healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 6 months in the Maintenance period.
Placebo
Dexlansoprazole placebo-matching capsules.
Interventions
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Dexlansoprazole
Dexlansoprazole delayed-release capsules.
Lansoprazole
Lansoprazole capsules.
Placebo
Dexlansoprazole placebo-matching capsules.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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U1111-1142-0320
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-390MR_301
Identifier Type: -
Identifier Source: org_study_id
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