NCT01269788

Comparing Omeprazole With Fluoxetine for Treatment of Non Erosive Reflux Disease and Its Subgroups: a Double-blind Placebo-controlled Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-erosive Reflux Disease

Interventions

Type	Name	Description
DRUG	Fluoxetine	20 mg , oral , daily 30 mins before breakfast, for 6 weeks
DRUG	Omeprazole	20 mg , oral , daily 30 mins before breakfast, for 6 weeks
DRUG	placebo	oral , daily 30 mins before breakfast, for 6 weeks
DRUG	Omeprazole	20 mg , oral , daily 30 mins before breakfast, for 6 weeks
DRUG	Fluoxetine	20 mg , oral , daily 30 mins before breakfast, for 6 weeks
DRUG	placebo	oral , daily 30 mins before breakfast, for 6 weeks

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-01-04
• Last updated: 2012-03-06

Locations

1 site across 1 country: Iran