Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Intervention: Dexlansoprazole; Lansoprazole; Placebo
Intervention description: Dexlansoprazole delayed-release capsules.; Lansoprazole capsules.; Dexlansoprazole placebo-matching capsules.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to determine the efficacy of dexlansoprazole compared to
      lansoprazole in healing erosive esophagitis (EE) in Chinese participants.
    

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.