The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Bezmialem Vakif University.
Recruitment status was  Not yet recruiting
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
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, see Learn About Clinical Studies.

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
Pantoprazole
Folic Acid
Vitamin B Complex
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hematinics
Hematologic Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014