Back to resultsThe Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia
Primary Purpose
Nonulcer Dyspepsia
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Pantoprazol
Folic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Nonulcer Dyspepsia
Eligibility 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
Sites / Locations
- Bezmialem medical faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
pantoprazole
folic acid
Arm Description
Outcomes
Primary Outcome Measures
Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01608750
Brief Title
The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia
Official Title
The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI) treatment in patients with functional dyspepsia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonulcer Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pantoprazole
Arm Type
Experimental
Arm Title
folic acid
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pantoprazol
Intervention Description
40mg/day, oral, 28 days
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
5 mg/day, oral, 28 days
Primary Outcome Measure Information:
Title
Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Bezmialem medical faculty
City
Istanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birol Baysal
Phone
+905057758585
Email
babbaysal@gmail.com
First Name & Middle Initial & Last Name & Degree
Birol Baysal
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia
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