Buspirone Plus Omeprazole for Functional Dyspepsia


This study is a double-blinded Randomised clinical trial aim to compare buspirone plus omeprazole with placebo plus omeprazole.

Full Title of Study: “Buspirone Plus Omeprazole for Functional Dyspepsia: A Randomised Placebo Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: March 1, 2017


  • Drug: Buspirone
    • Buspirone 5mg used QID a day after meal plus 20mg omeprazole before breakfast.
  • Drug: Placebo Oral Tablet
    • Buspirone placebo QID after meal plus 20mg omeprazole before breakfast.

Arms, Groups and Cohorts

  • Experimental: Buspirone plus Omeprazole
  • Placebo Comparator: Placebo plus Omeprazole

Clinical Trial Outcome Measures

Primary Measures

  • 70 patients With functional dyspepsia symptoms, Change From Baseline by asking about symptoms at 4 Weeks after using buspirone or placebo
    • Time Frame: 4 weeks taking buspirone plus omeprasole or taking placebo plus omeprasloe
    • Global symptom measured through a checklist of dyspepsia symptoms at first visit and four weeks after

Participating in This Clinical Trial

Inclusion Criteria

  • being over 18-year-old, Rome III criteria for FD
  • normal upper endoscopy within five years
  • negative Urease test for H-pylori
  • acceptance informed concept form.

Exclusion Criteria

  • denied to get these medications
  • taking other drugs for FD
  • patients with the organic gastrointestinal disorder

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Isfahan University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Meisam AbdarEsfahani, Mediacal Doctor – Isfahan University of Medical Sciences

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