Buspirone Plus Omeprazole for Functional Dyspepsia

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

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

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Drug: Buspirone; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buspirone plus Omeprazole	Drug: Buspirone; Buspirone 5mg used QID a day after meal plus 20mg omeprazole before breakfast.; Other Names: Omeprazole
Placebo Comparator: Placebo plus Omeprazole	Drug: Placebo Oral Tablet; Buspirone placebo QID after meal plus 20mg omeprazole before breakfast.; Other Names: omeprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 19, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Functional Dyspepsia
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Anti-Anxiety Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Buspirone; Omeprazole
• Other Study ID Numbers: 166681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No