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Buspirone Plus Omeprazole for Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03444831
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
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

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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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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Responsible Party: Meisam AbdarEsfahani, Mediacal Doctor, Isfahan University of Medical Sciences Identifier: NCT03444831    
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

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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:
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Signs and Symptoms, Digestive
Signs and Symptoms
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