A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
Condition: Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      Reflux (acid and non-acid) mainly occurs during transient LES relaxations (TLESRs). The
      gamma-aminobutyric acid (GABA) receptor type B agonist baclofen was shown to inhibit TLESRs,
      thereby significantly decreasing acid reflux after a meal in healthy controls and in patients
      with GERD.

      The primary objective of this study is to assess the efficacy (assessed by reflux symptom
      questionnaire and pH-impedance recordings) of baclofen 10mg three times daily vs. placebo in
      GERD patients with an incomplete response to PPI therapy.

      The secondary objective is to assess the predictive value of reflux assessment (by
      pH-impedance recordings) on the primary outcome.
    

Detailed description: 
      This is a randomized, parallel, double-blind, placebo-controlled, out-patient, single-center
      study. Eligible subjects will be randomly assigned to receive either oral baclofen 10 mg or
      placebo t.i.d for a period 4 weeks. After 4 weeks all patients will be given the standard
      dose of baclofen 10 mg t.i.d. (open label), for another 4 weeks. The b.i.d. PPI therapy will
      be continued for the entire study duration.

      Approximately 90 evaluable subjects with typical GERD symptoms (heartburn and/or
      regurgitation) will participate in this study and will be randomized on a 1:1 basis: 45
      subjects each will be in the placebo and baclofen 10 mg three times daily group. Subjects
      will be considered to have completed the study if they complete the week 4 visit.

      Medication will consist of identically-looking capsules of baclofen or placebo. Patients will
      take 1 capsule containing 5 mg baclofen with meals t.i.d for 7 days and then 1 capsule
      containing 10 mg baclofen with meals t.i.d for the remaining 21 days.

      Prior to visit 1, all subjects included in the study will undergo a 24 hr pH-impedance study
      which was requested by the treating physician. This investigation is part of the standard
      clinical work up and will not be part of the study protocol.

      Informed consent is to be signed and dated by the subject before any study related procedures
      are performed. The date of each visit to the clinic and the date and time of the last dose of
      test article will be recorded.

      Throughout the study patients will be asked to complete daily a short questionnaire (ReQuest)
      for reflux symptoms.
    

Intervention name(s): Baclofen; Placebos
Intervention type(s): Drug; Other
Intervention description(s): baclofen 10mg tid for 4 weeks; placebo tid for 4 weeks
Other intervention name(s): Lioresal
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, parallel, double-blind, placebo-controlled, out-patient, single-center study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment