Buspirone Plus Omeprazole for Functional Dyspepsia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03444831

Enrollment

Registered

2018-02-23

Start date

2016-03-01

Completion date

2017-04-01

Last updated

2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Keywords

Functional Dyspepsia

Brief summary

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

Interventions

DRUGBuspirone

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

DRUGPlacebo Oral Tablet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026