The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia

May 30, 2012 updated by: Birol Baysal, Bezmialem Vakif University

The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.

The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI) treatment in patients with functional dyspepsia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem medical faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 18-45 years with symptoms of dyspepsia,
  • no evidence of organic disease.

Exclusion Criteria:

  • Patients with alarm symptoms,
  • Severe concomitant illness,
  • Pregnancy or lactation,
  • Alcohol or drug abuse,
  • Use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, H2 receptor blockers, bismuth, or proton pump inhibitors in the preceding two weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pantoprazole
Drug: Pantoprazol
40mg/day, oral, 28 days
Placebo Comparator: folic acid
Drug: Folic Acid
5 mg/day, oral, 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

May 28, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (Estimate)

May 31, 2012

Study Record Updates

Last Update Posted (Estimate)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.BAV.0.05.05/331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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