Buspirone Plus Omeprazole for Functional Dyspepsia

Phase 4

Completed

• Conditions: Dyspepsia
• Interventions: Drug: Placebo Oral Tablet; Drug: Buspirone

• Registration Number: NCT03444831
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-04-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-19
• Last Update Submitted: 2018-02-19
• Study First Posted: 2018-02-23
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus Omeprazole	Placebo Oral Tablet	-
Buspirone plus Omeprazole	Buspirone	-

Primary Outcome Measures

Name	Time	Method
70 patients With functional dyspepsia symptoms, Change From Baseline by asking about symptoms at 4 Weeks after using buspirone or placebo	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