Nonulcer DyspepsiaPhase 4NCT01608750
The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia
A Phase 4 study testing Pantoprazol and Folic Acid in people with Nonulcer Dyspepsia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI) treatment in patients with functional dyspepsia. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Nonulcer Dyspepsia
- What is being tested?
- Pantoprazol and Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-45 years with symptoms of dyspepsia,
- no evidence of organic disease.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem medical faculty
Istanbul
Birol Baysal, +905057758585, babbaysal@gmail.com
Birol Baysal
About this study
Official title: The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.
The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI) treatment in patients with functional dyspepsia.
- Conditions
- Nonulcer Dyspepsia
- Being tested
- Pantoprazol, Folic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazolDrug
40mg/day, oral, 28 days
Folic AcidDrug
5 mg/day, oral, 28 days
| Study group | Role | What they receive |
|---|---|---|
| pantoprazole | Experimental | Not described Receives: Drug: Pantoprazol |
| folic acid | Placebo comparator | Not described Receives: Drug: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonulcer DyspepsiaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birol Baysal, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608750
- Sponsor's protocol ID
- B.30.2.BAV.0.05.05/331
- Status last verified
- May 2012
- First submitted
- 28 May 2012
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT01608750
- Acronym / sponsor ID
- B.30.2.BAV.0.05.05/331
- Conditions
- Nonulcer Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI) treatment in patients with functional dyspepsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pantoprazole | Experimental | Drug: Pantoprazol |
| folic acid | Placebo comparator | Drug: Folic Acid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 18-45 years with symptoms of dyspepsia,
- no evidence of organic disease.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantoprazol40mg/day, oral, 28 days | Drug | pantoprazole |
| Folic Acid5 mg/day, oral, 28 days | Drug | folic acid |
Primary outcome
Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pantoprazol and Folic Acid in people with Nonulcer Dyspepsia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2012.