Functional DyspepsiaPhase 4NCT00990405
Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
A Phase 4 study testing Lansoprzole+Amoxicillin+Clarithromycin in people with Functional Dyspepsia and Helicobacter Pylori Infection, run by Korean College of Helicobacter and Upper Gastrointestinal Research at 1 site in South Korea.
Trial summary
The role of Helicobacter pylori infection in functional dyspepsia remains controversial. Several randomized controlled trials in western countries have shown no significant advantage over placebo. But some recent studies in Asian population were different compared to the result of studies in the Western population. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Functional Dyspepsia, Helicobacter Pylori Infection
- What is being tested?
- Lansoprzole+Amoxicillin+Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Dec 2010
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Functional dyspepsia by Rome III criteria
- Normal endoscopic findings
- H. pylori positive by Urea breath test
Who cannot join
- Patients with severe concomitant systemic disease
- Patients with GI surgery
- Females with pregnancy or breast-feeding
- Irritable bowel syndrome, inflammatory bowel disease
- Duodenal Ulcer, Gastric Ulcer, GI bleeding
- History of eradication therapy of Helicobacter pylori
- Malignancy
- Psychosomatic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korean Society of Helicobacter and Upper GI Research
Seoul, Seoul, 135-87
About this study
Official title: Phase 4 Study of Helicobacter Pylori Eradication Therapy
The role of Helicobacter pylori infection in functional dyspepsia remains controversial. Several randomized controlled trials in western countries have shown no significant advantage over placebo. But some recent studies in Asian population were different compared to the result of studies in the Western population. At the present time, it seems to be difficult to conclude the efficacy of the H.pylori eradication therapy in patients with H. pylori-infected functional dyspepsia.
The investigators hypothesize that eradication of Helicobacter pylori has a sustained global symptom improvement in patients with H. pylori infected functional dyspepsia.
Read the detailed description
Functional dyspepsia: diagnosed by Rome III criteria of Functional gastrointestinal disorder Treatment regimen: Combination of proton pump inhibitor, Amoxicillin, Clarithromycin for 7 days Placebo: Same shaped placebo drugs
- Being tested
- Lansoprzole+Amoxicillin+Clarithromycin
- Keywords
- Rome III criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprzole+Amoxicillin+ClarithromycinDrug
Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole+Clarithromycin+Amoxycillin | Experimental | Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days Receives: Drug: Lansoprzole+Amoxicillin+Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)
Measured: Symptom assessment at 8 weeks after eradication
Secondary outcomes (4)
To improves the quality of life
Measured: 1 year
Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy
Measured: 1 year
The improvement of 8 dyspeptic symptom
Measured: 1 year
The adequate relief of symptom
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- 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, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean College of Helicobacter and Upper Gastrointestinal Research
- Sponsor type
- University, hospital or other
- Investigators
- Sang-Young Seol, Professor, Study chair, Korean Society of Helicobacter and Upper Gastrointestinal Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990405
- Sponsor's protocol ID
- KoreanCHUGR05
- Status last verified
- Oct 2009
- First submitted
- 5 Oct 2009
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Helicobacter Pylori Eradication Therapy
- ClinicalTrials.gov ID
- NCT00990405
- Acronym / sponsor ID
- KoreanCHUGR05
- Keywords
- Rome III criteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Korean College of Helicobacter and Upper Gastrointestinal ResearchUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 6 Oct 2009 (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 role of Helicobacter pylori infection in functional dyspepsia remains controversial. Several randomized controlled trials in western countries have shown no significant advantage over placebo. But some recent studies in Asian population were different compared to the result of studies in the Western population. At the present time, it seems to be difficult to conclude the efficacy of the H.pylori eradication therapy in patients with H. pylori-infected functional dyspepsia.
The investigators hypothesize that eradication of Helicobacter pylori has a sustained global symptom improvement in patients with H. pylori infected functional dyspepsia.
Detailed description
Functional dyspepsia: diagnosed by Rome III criteria of Functional gastrointestinal disorder Treatment regimen: Combination of proton pump inhibitor, Amoxicillin, Clarithromycin for 7 days Placebo: Same shaped placebo drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole+Clarithromycin+Amoxycillin | Experimental | Drug: Lansoprzole+Amoxicillin+ClarithromycinLansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Functional dyspepsia by Rome III criteria
- Normal endoscopic findings
- H. pylori positive by Urea breath test
Key exclusion criteria (8 listed)
- Patients with severe concomitant systemic disease
- Patients with GI surgery
- Females with pregnancy or breast-feeding
- Irritable bowel syndrome, inflammatory bowel disease
- Duodenal Ulcer, Gastric Ulcer, GI bleeding
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 |
|---|---|---|
| Lansoprzole+Amoxicillin+ClarithromycinLansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days | Drug | Lansoprazole+Clarithromycin+Amoxycillin |
Primary outcome
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)
Time frame: Symptom assessment at 8 weeks after eradication
4 secondary outcomes
To improves the quality of life
Time frame: 1 year
Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy
Time frame: 1 year
The improvement of 8 dyspeptic symptom
Time frame: 1 year
The adequate relief of symptom
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
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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.
Sang-Young Seol, Professor study chair
Korean Society of Helicobacter and Upper Gastrointestinal Research
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 Lansoprzole+Amoxicillin+Clarithromycin in people with Functional Dyspepsia and Helicobacter Pylori Infection, run by Korean College of Helicobacter and Upper Gastrointestinal Research at 1 site in South Korea.
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 3 inclusion and 8 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 6 Oct 2009. 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 South Korea. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy) (time frame: Symptom assessment at 8 weeks after eradication). 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 6 Oct 2009.