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The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT01608750
Recruitment Status : Unknown
Verified May 2012 by Birol Baysal, Bezmialem Vakif University.
Recruitment status was:  Not yet recruiting
First Posted : May 31, 2012
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):
Birol Baysal, Bezmialem Vakif University

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

Condition or disease Intervention/treatment Phase
Nonulcer Dyspepsia Drug: Pantoprazol Drug: Folic Acid Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.
Study Start Date : June 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale. [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: May 2012

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