The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia

Nonulcer Dyspepsia Clinical Trial

Official title:

The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01608750
• Other study ID #: B.30.2.BAV.0.05.05/331
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 28, 2012
• Last updated: May 30, 2012
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2012
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Nonulcer Dyspepsia

Intervention

Drug:
• Pantoprazol
40mg/day, oral, 28 days
• Folic Acid
5 mg/day, oral, 28 days

Locations

Country	Name	City	State
Turkey	Bezmialem medical faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.		one year	No