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Buspirone Plus Omeprazole for Functional Dyspepsia

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03444831
Collaborator
(none)
70
Enrollment
2
Arms
13
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Buspirone Plus Omeprazole for Functional Dyspepsia: A Randomised Placebo Clinical Trial
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Isfahan University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Meisam AbdarEsfahani, Mediacal Doctor, Isfahan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03444831
    Other Study ID Numbers:
    • 166681
    First Posted:
    Feb 23, 2018
    Last Update Posted:
    Feb 23, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Meisam AbdarEsfahani, Mediacal Doctor, Isfahan University of Medical Sciences
    Functional Dyspepsia
    Additional relevant MeSH terms:
    Dyspepsia
    Buspirone
    Omeprazole

    Study Results

    No Results Posted as of Feb 23, 2018