Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Dexlansoprazole MR QD
Intervention description: Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esophageal Reflux; Gastro-Esophageal Reflux; Gastroesophageal Reflux Disease; GERD; Regurgitation, Gastric; Heartburn; Drug Therapy

Summary:

      The purpose of this study is to determine if patients with well-controlled heartburn symptoms
      on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to
      once-daily (QD) dexlansoprazole modified release (MR) 30 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Prior to any study-specific procedures being performed, the participant voluntarily
             signs an Investigational Review Board-approved informed consent form (ICF) and any
             privacy statement/authorization form required (eg, The Health Insurance Portability
             and Accountability Act (HIPAA) authorization)

          2. Has a history of gastroesophageal reflux disease symptom, including heartburn, prior
             to therapy, who are currently being treated with twice daily proton pump inhibitors,
             excluding Dexilant (dexlansoprazole).

          3. Taking a stable dose of any twice daily proton pump inhibitors for less than or equal
             to 1 year and greater than 8 weeks prior to Screening.

          4. Participant is well-controlled on their current twice daily proton pump inhibitors.

          5. Females cannot be nursing and must have a negative urine pregnancy test at Day -1 or
             be of non-childbearing potential. If females are of child bearing potential, must have
             a negative serum human chorionic gonadotropin (hCG) pregnancy test during Screening
             and on an acceptable form of contraception, or have had bilateral tubal ligation if
             performed a minimum of 90 days prior to Day 1.

        Exclusion Criteria:

          1. Has a history of co-existing diseases affecting the esophagus, history of radiation
             therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as
             sclerotherapy to the esophagus.

          2. Has active gastric or duodenal ulcers during the 30 days prior to Screening.

          3. Has acute upper gastrointestinal hemorrhage during the 30 days prior to Screening.

          4. Has current or historical evidence of Zollinger-Ellison syndrome or other
             hypersecretory condition.

          5. Has known hypersensitivity to any proton pump inhibitor or any component of
             dexlansoprazole MR.

          6. Use of any Histamine type-2 receptor antagonist or antacids during Screening or
             anticipated use during the study treatment period.

          7. Use of the following medications 7 days prior to Screening or anticipated use during
             the study:

               -  Sucralfate.

               -  Misoprostol.

               -  Systemic corticosteroids.

               -  Prokinetics (to include metoclopramide, cisapride, tegaserod).

               -  Bisphosphonates during the 6 months prior to Screening or anticipated use during
                  the study.

               -  Chronic use (> 12 doses per month) of nonsteroidal anti-inflammatory drugs

               -  Drugs with significant anticholinergic effects such as tricyclic antidepressants
                  or drugs with central nervous system effects that could mask perception of
                  symptoms.

               -  Any investigational drug(s) within 30 days of Screening.

          8. Has received blood products within the 3 months prior to Screening.

          9. History of alcohol abuse or illegal drug use or drug addiction in the 12 months prior
             to Screening.

         10. Evidence of uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other
             abnormality, which may impact the ability of the participant to participate or
             potentially confound the study results.

         11. Atypical manifestations of gastroesophageal reflux disease.

         12. Has abnormal screening laboratory values that suggest a clinically significant
             underlying disease or condition.

         13. Cancer within 5 years prior to Screening.

         14. Is known to have acquired immunodeficiency syndrome.

         15. Has any condition that is likely to require inpatient surgery during the course of the
             study.

         16. Surgery of the acute upper gastrointestinal tract, including bariatric.

         17. Is in the opinion of the investigator unable to comply with the requirements of the
             study or are unsuitable for any reason.