Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents
Condition: Gastroesophageal Reflux Disease; Erosive Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Heartburn
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effectiveness of treatment with once
      daily oral administration of dexlansoprazole delayed-release capsules in adolescents with
      erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.
    

Detailed description: 
      The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being
      tested to treat adolescents who have erosive esophagitis and heartburn and maintenance of
      healing of EE.

      The study planned to enroll approximately 60 patients.

      The study consisted of 3 periods:

        1. Screening ((21 [+5] days)

        2. Treatment (8 weeks for healing, 16 weeks for maintenance),

        3. Post-Treatment Follow-up (up to 3 months).

      During screening, participants used an electronic diary (eDiary) daily to document the
      presence of daytime and nighttime heartburn symptoms and the degree to which heartburn hurt
      (hereinafter referred to as severity), and to record their use of rescue medication
      (antacid).

      During the first 8 week treatment period, all participants received dexlansoprazole 60 mg,
      once daily (QD). At the Week 8 visit, participants underwent endoscopy to assess healing of
      EE. Participants whose EE had not healed were discontinued from the study.

      Participants whose EE had healed were randomly assigned (by chance, like flipping a coin) to
      one of the two treatment groups-which will remain undisclosed to the patient and study doctor
      during the study (unless there is an urgent medical need):

        -  dexlansoprazole 30 mg QD

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient

      All participants were asked to take one tablet each morning without regard to food throughout
      the study. Throughout both phases of the Treatment Period, all participants continued to use
      the eDiary to document the presence or absence and severity of daytime and nighttime
      heartburn symptoms and the use of rescue medication.

      This multi-center trial was conducted worldwide. The overall time to participate in this
      study was 39 weeks. Participants made multiple visits to the clinic, and were contacted by
      telephone during the study
    

Intervention name(s): Dexlansoprazole; Dexlansoprazole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexlansoprazole capsules; Dexlansoprazole capsules; Dexlansoprazole placebo-matching capsules
Other intervention name(s): Dexilant; Dexilant
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy