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Buspirone Plus Omeprazole for Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT03444831
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Meisam AbdarEsfahani, Isfahan University of Medical Sciences

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
Dyspepsia Drug: Buspirone Drug: Placebo Oral Tablet Phase 4

Study Type : Interventional  (Clinical Trial)
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 : March 1, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Buspirone plus Omeprazole Drug: Buspirone
Buspirone 5mg used QID a day after meal plus 20mg omeprazole before breakfast.
Other Name: Omeprazole

Placebo Comparator: Placebo plus Omeprazole Drug: Placebo Oral Tablet
Buspirone placebo QID after meal plus 20mg omeprazole before breakfast.
Other Name: omeprazole




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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Meisam AbdarEsfahani, Mediacal Doctor, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03444831     History of Changes
Other Study ID Numbers: 166681
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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, Isfahan University of Medical Sciences:
Functional Dyspepsia

Additional relevant MeSH terms:
Omeprazole
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Buspirone
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents