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NCT03444831 Clinical Trial

Buspirone Plus Omeprazole for Functional Dyspepsia

Dyspepsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03444831
Other study ID # 166681
Secondary ID
Status Completed
Phase Phase 4
First received February 10, 2018
Last updated February 19, 2018
Start date March 1, 2016
Est. completion date April 1, 2017

Study information
Verified date February 2018
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date April 1, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Outcome
Type Measure Description Time frame Safety issue
Primary 70 patients With functional dyspepsia symptoms, Change From Baseline by asking about symptoms at 4 Weeks after using buspirone or placebo Global symptom measured through a checklist of dyspepsia symptoms at first visit and four weeks after 4 weeks taking buspirone plus omeprasole or taking placebo plus omeprasloe
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