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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
History of Changes
  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:

U.S. FDA Resources

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 May 23, 2013