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Buspirone Plus Omeprazole for Functional Dyspepsia

Primary Purpose

Dyspepsia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Buspirone
Placebo Oral Tablet
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Functional Dyspepsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Buspirone plus Omeprazole

    Placebo plus Omeprazole

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 10, 2018
    Last Updated
    February 19, 2018
    Sponsor
    Isfahan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03444831
    Brief Title
    Buspirone Plus Omeprazole for Functional Dyspepsia
    Official Title
    Buspirone Plus Omeprazole for Functional Dyspepsia: A Randomised Placebo Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    March 1, 2017 (Actual)
    Study Completion Date
    April 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Isfahan University of Medical Sciences

    4. Oversight

    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

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyspepsia
    Keywords
    Functional Dyspepsia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Buspirone plus Omeprazole
    Arm Type
    Experimental
    Arm Title
    Placebo plus Omeprazole
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Buspirone
    Other Intervention Name(s)
    Omeprazole
    Intervention Description
    Buspirone 5mg used QID a day after meal plus 20mg omeprazole before breakfast.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Oral Tablet
    Other Intervention Name(s)
    omeprazole
    Intervention Description
    Buspirone placebo QID after meal plus 20mg omeprazole before breakfast.
    Primary Outcome Measure Information:
    Title
    70 patients With functional dyspepsia symptoms, Change From Baseline by asking about symptoms at 4 Weeks after using buspirone or placebo
    Description
    Global symptom measured through a checklist of dyspepsia symptoms at first visit and four weeks after
    Time Frame
    4 weeks taking buspirone plus omeprasole or taking placebo plus omeprasloe

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Buspirone Plus Omeprazole for Functional Dyspepsia

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