Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Dexlansoprazole MR; Dexlansoprazole MR; Placebo
Intervention description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.; Dexlansoprazole MR 90 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: 908.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Erosive Gastroesophageal Reflux Disease(GERD),heartburn

Summary:

      The purpose of this study is to assess the efficacy and safety of daily treatment with
      Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD
      in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal
      reflux disease (GERD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main
             symptom as heartburn.

               -  History of episodes of heartburn for 6 months or longer prior to screening.

               -  History of episodes of heartburn for 4 or more days during the 7 days prior to
                  Day -1 as recorded in the electronic diary.

        Exclusion Criteria:

          -  Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2)
             receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study

          -  Erosive Esophagitis seen on endoscopy during study screening.

          -  Co-existing diseases affecting the esophagus.

          -  Abnormal laboratory values that suggest significant clinical disease.

          -  Known acquired immunodeficiency syndrome (AIDS)

          -  Females pregnant or lactating.

          -  History of Alcohol abuse.

          -  History of Cancer within 3 years prior to screening.

          -  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

          -  Need for continuous anticoagulant (blood thinner) therapy

          -  Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus

          -  History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring
             of mucosal tissue near the lower esophageal sphincter)

          -  Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory
             condition

          -  History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer

          -  Subjects who, in the opinion of the investigator, are unable to comply with the
             requirements of the study or are unsuitable for any reason.

          -  Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening
             endoscopy