Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients
Condition: Heartburn; Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Heartburn
Intervention: Dexlansoprazole; Placebo
Intervention description: Dexlansoprazole delayed-release capsule; Dexlansoprazole placebo-matching capsules
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

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).
    

Eligibility criteria:

        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.