A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Heartburn
Intervention: Dexlansoprazole; Placebo
Intervention description: 30 mg capsule, orally, once daily for 4 weeks; 1 capsule, 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: 305.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Non-Erosive Gastroesophageal Reflux Disease; GERD; heartburn; sleep disturbance; nocturnal Reflux

Summary:

      The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is
      effective in treating patients with night heartburn.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

          -  History of nocturnal heartburn and GERD associated sleep disturbances prior to
             screening.

          -  Meets both of the following criteria: 1) nocturnal heartburn severity of moderate,
             severe, or very severe on at least 3 of 7 nights and; 2) GERD related sleep
             disturbances on at least 3 of 7 nights.

          -  Subjects must have history of symptomatic GERD prior to screening with GERD symptoms
             that were responsive to acid-suppressive therapy.

        Exclusion Criteria:

          -  Erosive esophagitis visualized during the screening endoscopy.

          -  Allergy to any proton pump inhibitor drug (lansoprazole, omeprazole, rabeprazole,
             pantoprazole, esomeprazole), any component of Dexlansoprazole, or Gelusil/antacid.

          -  Active gastric or duodenal ulcers within 30 days prior to randomization.

          -  Upper gastrointestinal bleeding within 6 months prior to randomization.

          -  Co-existing diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal
             varices, scleroderma, viral or fungal infection, and/or Barrett's esophagus).

          -  History of radiation therapy or cryotherapy to the esophagus, caustic or
             physiochemical trauma such as sclerotherapy to the esophagus.

          -  Subject requiring dilation for esophageal strictures and/or strictures preventing
             passage of the endoscope during the screening endoscopy. Schatzki's ring (a ring of
             mucosal tissue near the lower esophageal sphincter) is acceptable.

          -  Has another condition that could be the primary cause of the subject's sleep
             disturbance.

          -  Evidence of uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other
             abnormality (other than the disease being studied) which may impact the ability of the
             subject to participate or potentially confound the trial results.

          -  Diagnosis of cancer (except basal cell carcinoma) within 5 years of screening.

          -  Has a condition likely to require surgery during the study.

          -  Currently diagnosed with acquired immunodeficiency syndrome (AIDS).

          -  Abnormal clinical laboratory values.

          -  History of alcoholism or drug addiction.

          -  Subject who works the night shift.

          -  Subject who is planning to travel beyond 3 time zones during the study.

          -  Chronic use (more than 12 doses/month) of non-steroidal anti-inflammatory drugs
             (NSAIDs), including cyclooxygenase-2 (COX 2) inhibitors within 30 days prior to
             randomization or anticipated use during the study.

          -  Use of the following medications during the 14 days prior to randomization or
             anticipated use during the study: proton pump inhibitors, sucralfate, misoprostol,
             corticosteroids, prokinetics, anticoagulant therapy, antiseizure medications (other
             than stable doses), psychotropic medications (other than stable doses), narcotic
             medications (occasional use allowed), bisphosphonates.

          -  Use of sleep medications, first generation antihistamines, benzodiazepines, modified
             cyclic antidepressants, antianxiety medications or drugs with significant
             anticholinergic effects such as tricyclic antidepressants or drugs with central
             nervous system effects that could mask perception of symptoms (eg, selective-serotonin
             reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors). However,
             subjects who remain on a stable regimen and dose of these medications during the 90
             days prior to randomization and who agree to maintain the same regimen and dose during
             the trial will qualify. Also, short term use of anticholinergics for trial related
             procedures is not exclusionary. Second generation antihistamines are not excluded.

          -  Use of histamine (H2) receptor antagonists or antacids (except for trial supplied
             Gelusil) during the screening period or anticipated use during the treatment period.