NCT01608750

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 31, 2012

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

May 28, 2012

Last Update Submit

May 30, 2012

Conditions

Nonulcer Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.

    one year

Study Arms (2)

pantoprazole

EXPERIMENTAL
Drug: Pantoprazol

folic acid

PLACEBO COMPARATOR
Drug: Folic Acid

Interventions

PantoprazolDRUG

40mg/day, oral, 28 days

pantoprazole
Folic AcidDRUG

5 mg/day, oral, 28 days

folic acid

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-45 years with symptoms of dyspepsia,
  • no evidence of organic disease.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem medical faculty

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

PantoprazoleFolic Acid

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPterinsPteridines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist

Study Record Dates

First Submitted

May 28, 2012

First Posted

May 31, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

May 31, 2012

Record last verified: 2012-05

Locations

TU(1)