NCT03444831

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 10, 2018

Last Update Submit

February 19, 2018

Conditions

Dyspepsia

Keywords

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Buspirone plus Omeprazole

EXPERIMENTAL
Drug: Buspirone

Placebo plus Omeprazole

PLACEBO COMPARATOR
Drug: Placebo Oral Tablet

Interventions

BuspironeDRUG

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

Also known as: Omeprazole
Buspirone plus Omeprazole
Placebo Oral TabletDRUG

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

Also known as: omeprazole
Placebo plus Omeprazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • denied to get these medications
  • taking other drugs for FD
  • patients with the organic gastrointestinal disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyspepsia

Interventions

BuspironeOmeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPolycyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsPyridinesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mediacal Doctor

Study Record Dates

First Submitted

February 10, 2018

First Posted

February 23, 2018

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02