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.

Completed

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Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buspirone

Drug

Buspirone 5mg used QID a day after meal plus 20mg omeprazole before breakfast.

Other names: Omeprazole

Placebo oral tablet

Drug

Buspirone placebo QID after meal plus 20mg omeprazole before breakfast.

Other names: omeprazole

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Buspirone Plus Omeprazole for Functional Dyspepsia: A Randomised Placebo Clinical Trial

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Feb 23, 2018
Registry last updated: Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed