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The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia

NCT ID: NCT01608750

Last Updated: 2012-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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

Detailed Description

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Conditions

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Nonulcer Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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pantoprazole

Group Type EXPERIMENTAL

Pantoprazol

Intervention Type DRUG

40mg/day, oral, 28 days

folic acid

Group Type PLACEBO_COMPARATOR

Folic Acid

Intervention Type DRUG

5 mg/day, oral, 28 days

Interventions

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Pantoprazol

40mg/day, oral, 28 days

Intervention Type DRUG

Folic Acid

5 mg/day, oral, 28 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Birol Baysal

Gastroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bezmialem medical faculty

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Facility Contacts

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Birol Baysal

Role: primary

Other Identifiers

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B.30.2.BAV.0.05.05/331

Identifier Type: -

Identifier Source: org_study_id