The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia

This study is not yet open for participant recruitment.
Verified May 2012 by Bezmialem Vakif University
Sponsor:
Information provided by (Responsible Party):
Birol Baysal, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT01608750
First received: May 28, 2012
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Nonulcer Dyspepsia
Drug: Pantoprazol
Drug: Folic Acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.

Resource links provided by NLM:


Further study details as provided by Bezmialem Vakif University:

Primary Outcome Measures:
  • Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pantoprazole Drug: Pantoprazol
40mg/day, oral, 28 days
Placebo Comparator: folic acid Drug: Folic Acid
5 mg/day, oral, 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608750

Locations
Turkey
Bezmialem medical faculty Not yet recruiting
Istanbul, Turkey
Contact: Birol Baysal    +905057758585    babbaysal@gmail.com   
Principal Investigator: Birol Baysal         
Sponsors and Collaborators
Bezmialem Vakif University
  More Information

No publications provided

Responsible Party: Birol Baysal, Gastroenterologist, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01608750     History of Changes
Other Study ID Numbers: B.30.2.BAV.0.05.05/331
Study First Received: May 28, 2012
Last Updated: May 30, 2012
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Folic Acid
Vitamin B Complex
Pantoprazole
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014