Comparing Omeprazole With Fluoxetine for Treatment of Non Erosive Reflux Disease and Its Subgroups: a Double-blind Placebo-controlled Clinical Trial
Condition: Non-erosive Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Gastro-esophageal reflux disease (GERD) is highly prevalent, affecting up to 20% of the adult
      population in North America. Up to 70% of GERD patients have non-erosive reflux disease
      (NERD), a term used to describe symptoms suggestive of GERD in patients with no endoscopic
      evidence of erosive esophagitis. NERD represents a heterogeneous group of patients whom are
      sub classified according to 24 hours-PH monitoring results and also symptom-acid association
      analysis(Symptom Index,SI).

      Treatment of NERD can be a challenge for clinicians. According to the many studies , the
      pooled rate for symptomatic response after a period of proton pomp inhibitor(PPIs)therapy as
      the most frequently used drug, in NERD patients is lower than for erosive esophagitis
      patients. It is also shown that acid exposure is much lower in NERD patients than those with
      erosive esophagitis and NERD patients are less likely to exhibit a strong association between
      heartburn symptoms and acid reflux events than patients with erosive oesophagitis.

      Furthermore, beside the high economic burden, there are concerns about the adverse effects of
      long time administration of PPIs.

      Several hypothesis has been proposed to describe low response rate of NERD patients to PPIs.
      One of the most acceptable theories is that patients with anxiety or depression and
      psychological problems are at an increased risk of developing reflux symptoms. On the other
      hand, pain modulators such as sertraline, a selective serotonin reuptake inhibitor(SSRI), and
      other antidepressants have been shown to improve symptoms in patients with functional
      gastrointestinal disorders like non cardiac chest pain.

      According to the above-mentioned tips, the investigators hypothesize that antidepressants
      like fluoxetine, as an SSRI, may have beneficial effects in improving symptoms of NERD
      patients.

      The purpose of this study is to compare the effect of omeprazole with fluoxetine and placebo
      for treatment of NERD patients and its subgroups who all experience reflux symptoms and have
      normal endoscopic findings.
    


Intervention name(s): Fluoxetine; Omeprazole; placebo; Omeprazole; Fluoxetine; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 20 mg , oral , daily 30 mins before breakfast, for 6 weeks; 20 mg , oral , daily 30 mins before breakfast, for 6 weeks; oral , daily 30 mins before breakfast, for 6 weeks; 20 mg , oral , daily 30 mins before breakfast, for 6 weeks; 20 mg , oral , daily 30 mins before breakfast, for 6 weeks; oral , daily 30 mins before breakfast, for 6 weeks
Intervention MeSH terms: Fluoxetine; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: non-erosive reflux disease; heartburn; functional; Antidepressive Agents, Second-Generation; Proton Pump Inhibitors