Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Dexlansoprazole MR; Dexlansoprazole MR; Placebo
Intervention description: Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.; Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.; Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 947.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux Disease(GERD); Heartburn

Summary:

      The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified
      release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and
      nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal
      reflux disease (GERD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects identifying their main symptom as a burning feeling in the mid epigastric
             area and/or chest area (ie, heartburn).

          -  Subject has a history of episodes of heartburn for 6 months or longer prior to
             Screening.

          -  Subject must have a history of episodes of heartburn for 4 or more days during the 7
             days prior to Day -1.

        Exclusion Criteria:

          -  Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of
             dilatation of esophageal strictures.

          -  Subjects with erosive esophagitis (EE) as shown by endoscopy.

          -  Evidence of uncontrolled systemic disease. Co-existing diseases affecting the
             esophagus. Current or history of Zollinger-Ellison syndrome.

          -  Subject has abnormal laboratory values.

          -  Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.

          -  Subject known to have acquired immunodeficiency syndrome (AIDS).

          -  Known hypersensitivity to any proton pump inhibitor (PPI), any component of
             Dexlansoprazole MR, or antacid.

          -  Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or
             sucralfate.

          -  Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or
             cyclo-oxygenase-2 (COX-2) inhibitors.

          -  Use of antacids (except for study-supplied Gelusil® ).

          -  Use of drugs with significant anticholinergic effects.

          -  Subjects who cannot discontinue the use of misoprostol or prokinetics

          -  Need for continuous anticoagulant therapy.

          -  Females who are pregnant or lactating.

          -  History of gastrointestinal surgery except for simple oversew of ulcer.

          -  History of cancer within 3 years prior to screening.

          -  Subject has participated in a previous Dexlansoprazole study.

          -  Subjects who, in the opinion of the investigator, are unable to comply with the
             requirements of the study or are unsuitable for any reason.