Functional DyspepsiaPhase 3HEROES-12NCT00404534
Helicobacter Eradication Relief of Dyspeptic Symptoms
A Phase 3 study testing Amoxicillin, Clarythromycin, Omeprazole for ten days in people with Functional Dyspepsia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Amoxicillin, Clarythromycin, Omeprazole for ten days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 407 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2006to Jun 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with more than 18 years
- Functional dyspepsia accordingly Rome III criteria
- Helicobacter pylori infection by two diagnostic tests
Who cannot join
- No concordance with informed consent
- Pregnant woman or breast feeding or no trust anticonceptional method
- Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia
- Previous treatment for Helicobacter pylori infection
- Previous surgery on esophagus, stomach or duodenum
- Hypersensitivity to the drugs in study
Show all 16Show fewer
- Proton pump inhibitor use in the previous 15 days
- H2-antagonists use in the previous 07 days
- Antibiotics use in the previous 30 days
- Patients unable to answer the study questionnaires
- Alcohol abuse
- Drug use
- Serious comorbidities
- Biliary colic
- Irritable bowel syndrome
- Gastroesophageal Reflux Disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Dyspeptic Symptoms Evolution After Eradication of Helicobacter Pylori in Patients With Different Endoscopic Findings: a Randomized Double-blind Placebo-controlled Clinical Trial With 12 Months of Follow-up
A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group
Read the detailed description
Objective: investigate if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group
Design: A randomized double-blind placebo controlled clinical trial
Inclusion Criteria: Patients with more than 18 years, Functional dyspepsia accordingly Rome III criteria, Helicobacter pylori infection by two diagnostic tests
Exclusion Criteria: No concordance with informed consent; Pregnant woman or breast feeding or no trust anticonceptional method; Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia; Previous treatment for Helicobacter pylori infection; Previous surgery on esophagus, stomach or duodenum; Hypersensitivity to the drugs in study; Proton pump inhibitor use in the previous 15 days; H2-antagonists use in the previous 07 days; Antibiotics use in the previous 30 days; Patients unable to answer the study questionnaires; Alcohol abuse; Drug use; Serious comorbidities; Biliary colic; Irritable bowel syndrome; Gastroesophageal Reflux Disease
Interventions: amoxicillin, clarythromycin, omeprazole for 10 days
Control: Placebo
Outcomes:
Primary: Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire Secondary: Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire; Need of rescue medication; Median difference of score between groups; Mean SF-36 scores evolution between groups; Lost of productivity measured by WPAI between groups
Visits: screening, baseline, 4, 8, 12 months
Endoscopic evaluation: screening, 12 months
Helicobacter detection methods: urease, histology (3 pathologists) performed at screening and 12 months
- Conditions
- Functional Dyspepsia
- Being tested
- Amoxicillin, Clarythromycin, Omeprazole for ten days
- Keywords
- functional dyspepsia, Helicobacter pylori, Anti-Inflammatory Agents, Non-Steroidal, Gastritis
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin, Clarythromycin, Omeprazole for ten daysDrug
Amoxicillin 1000 mg BID, clarythromycin 500 mg BID for ten days in the experimental group and placebo of Amoxicillin 1000 mg BID and placebo of clarythromycin 500 mg BID in the placebo comparator. Both groups receive omeprazole 20 mg bid for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Amoxicillin 1000 mg BID, clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days Receives: Drug: Amoxicillin, Clarythromycin, Omeprazole for ten days |
| 2 | Placebo comparator | Placebo of Amoxicillin 1000 mg BID, placebo of clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days Receives: Drug: Amoxicillin, Clarythromycin, Omeprazole for ten days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
Measured: the last visit among the antecipated visits (4, 8 and 12 months)
Secondary outcomes (6)
Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
Measured: the last visit among the antecipated visits (4, 8 and 12 months)
Need of rescue medication
Measured: 4, 8 and 12 months
Median difference of score between groups
Measured: the last visit among the antecipated visits (4, 8 and 12 months)
Mean SF-36 scores evolution between groups
Measured: 12 months
Lost of productivity measured by WPAI between groups
Measured: 12 months
Adverse Events
Measured: 4 , 8 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Aché Laboratórios Farmacêuticos Ltda
- Responsible party
- Sponsor
- Investigators
- Luiz E Mazzoleni, MD, MsC, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do SulCarlos F Francesconi, MD, PhD, Study chair, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do SulGuilherme B Sander, MD, MsC, Study chair, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404534
- Sponsor's protocol ID
- 05-422
- Acronym
- HEROES-12
- Status last verified
- Mar 2010
- First submitted
- 27 Nov 2006
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mazzoleni LE, Sander GB, Ott EA, Barros SG, Francesconi CF, Polanczyk CA, Wortmann AC, Theil AL, Fritscher LG, Rivero LF, Cartell A, Edelweiss MI, Uchoa DM, Prolla JC. Clinical outcomes of eradication of Helicobacter pylori in nonulcer dyspepsia in a population with a high prevalence of infection: results of a 12-month randomized, double blind, placebo-controlled study. Dig Dis Sci. 2006 Jan;51(1):89-98. doi: 10.1007/s10620-006-3090-6.
PubMed 16416218Ott EA, Mazzoleni LE, Edelweiss MI, Sander GB, Wortmann AC, Theil AL, Somm G, Cartell A, Rivero LF, Uchoa DM, Francesconi CF, Prolla JC. Helicobacter pylori eradication does not cause reflux oesophagitis in functional dyspeptic patients: a randomized, investigator-blinded, placebo-controlled trial. Aliment Pharmacol Ther. 2005 May 15;21(10):1231-9. doi: 10.1111/j.1365-2036.2005.02461.x.
PubMed 15882244Sander GB, Mazzoleni LE, Francesconi CF, Wortmann AC, Ott EA, Theil A, Da Cruz PV, Da Silva AC, Oliveira L, Beheregaray S, Matioti S, Somm G, Goldim JR. Development and validation of a cross-cultural questionnaire to evaluate nonulcer dyspepsia: the Porto Alegre Dyspeptic Symptoms Questionnaire (PADYQ). Dig Dis Sci. 2004 Nov-Dec;49(11-12):1822-9. doi: 10.1007/s10620-004-9578-z.
PubMed 15628711Mazzoleni LE, Sander GB, Francesconi CF, Mazzoleni F, Uchoa DM, De Bona LR, Milbradt TC, Von Reisswitz PS, Berwanger O, Bressel M, Edelweiss MI, Marini SS, Molina CG, Folador L, Lunkes RP, Heck R, Birkhan OA, Spindler BM, Katz N, Colombo Bda S, Guerrieri PP, Renck LB, Grando E, Hocevar de Moura B, Dahmer FD, Rauber J, Prolla JC. Helicobacter pylori eradication in functional dyspepsia: HEROES trial. Arch Intern Med. 2011 Nov 28;171(21):1929-36. doi: 10.1001/archinternmed.2011.533.
PubMed 22123802Sander GB, Mazzoleni LE, Francesconi CF, Balbinotto G, Mazzoleni F, Wortmann AC, Cardoso Ide Q, Klamt AL, Milbradt TC; Helicobacter Eradication Relief of Dyspetic Symptoms Trial Investigators. Influence of organic and functional dyspepsia on work productivity: the HEROES-DIP study. Value Health. 2011 Jul-Aug;14(5 Suppl 1):S126-9. doi: 10.1016/j.jval.2011.05.021.
PubMed 21839884
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyspeptic Symptoms Evolution After Eradication of Helicobacter Pylori in Patients With Different Endoscopic Findings: a Randomized Double-blind Placebo-controlled Clinical Trial With 12 Months of Follow-up
- ClinicalTrials.gov ID
- NCT00404534
- Acronym / sponsor ID
- HEROES-12 / 05-422
- Conditions
- Functional Dyspepsia
- Keywords
- functional dyspepsia, Helicobacter pylori, Anti-Inflammatory Agents, Non-Steroidal, Gastritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Aché Laboratórios Farmacêuticos Ltda
- Study start
- Oct 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Nov 2006 (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.
A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group
Detailed description
Objective: investigate if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group
Design: A randomized double-blind placebo controlled clinical trial
Inclusion Criteria: Patients with more than 18 years, Functional dyspepsia accordingly Rome III criteria, Helicobacter pylori infection by two diagnostic tests
Exclusion Criteria: No concordance with informed consent; Pregnant woman or breast feeding or no trust anticonceptional method; Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia; Previous treatment for Helicobacter pylori infection; Previous surgery on esophagus, stomach or duodenum; Hypersensitivity to the drugs in study; Proton pump inhibitor use in the previous 15 days; H2-antagonists use in the previous 07 days; Antibiotics use in the previous 30 days; Patients unable to answer the study questionnaires; Alcohol abuse; Drug use; Serious comorbidities; Biliary colic; Irritable bowel syndrome; Gastroesophageal Reflux Disease
Interventions: amoxicillin, clarythromycin, omeprazole for 10 days
Control: Placebo
Outcomes:
Primary: Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire Secondary: Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire; Need of rescue medication; Median difference of score between groups; Mean SF-36 scores evolution between groups; Lost of productivity measured by WPAI between groups
Visits: screening, baseline, 4, 8, 12 months
Endoscopic evaluation: screening, 12 months
Helicobacter detection methods: urease, histology (3 pathologists) performed at screening and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Amoxicillin, Clarythromycin, Omeprazole for ten daysAmoxicillin 1000 mg BID, clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days |
| 2 | Placebo comparator | Drug: Amoxicillin, Clarythromycin, Omeprazole for ten daysPlacebo of Amoxicillin 1000 mg BID, placebo of clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with more than 18 years
- Functional dyspepsia accordingly Rome III criteria
- Helicobacter pylori infection by two diagnostic tests
Key exclusion criteria (16 listed)
- No concordance with informed consent
- Pregnant woman or breast feeding or no trust anticonceptional method
- Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia
- Previous treatment for Helicobacter pylori infection
- Previous surgery on esophagus, stomach or duodenum
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 |
|---|---|---|
| Amoxicillin, Clarythromycin, Omeprazole for ten daysAmoxicillin 1000 mg BID, clarythromycin 500 mg BID for ten days in the experimental group and placebo of Amoxicillin 1000 mg BID and placebo of clarythromycin 500 mg BID in the placebo comparator. Both groups receive omeprazole 20 mg bid for 10 days. | Drug | 1, 2 |
Primary outcome
Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
Time frame: the last visit among the antecipated visits (4, 8 and 12 months)
6 secondary outcomes
Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
Time frame: the last visit among the antecipated visits (4, 8 and 12 months)
Need of rescue medication
Time frame: 4, 8 and 12 months
Median difference of score between groups
Time frame: the last visit among the antecipated visits (4, 8 and 12 months)
Mean SF-36 scores evolution between groups
Time frame: 12 months
Lost of productivity measured by WPAI between groups
Time frame: 12 months
Adverse Events
Time frame: 4 , 8 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Background: PubMed 16416218Mazzoleni LE, Sander GB, Ott EA, Barros SG, Francesconi CF, Polanczyk CA, Wortmann AC, Theil AL, Fritscher LG, Rivero LF, Cartell A, Edelweiss MI, Uchoa DM, Prolla JC. Clinical outcomes of eradication of Helicobacter pylori in nonulcer dyspepsia in a population with a high prevalence of infection: results of a 12-month randomized, double blind, placebo-controlled study. Dig Dis Sci. 2006 Jan;51(1):89-98. doi: 10.1007/s10620-006-3090-6.
- Background: PubMed 15882244Ott EA, Mazzoleni LE, Edelweiss MI, Sander GB, Wortmann AC, Theil AL, Somm G, Cartell A, Rivero LF, Uchoa DM, Francesconi CF, Prolla JC. Helicobacter pylori eradication does not cause reflux oesophagitis in functional dyspeptic patients: a randomized, investigator-blinded, placebo-controlled trial. Aliment Pharmacol Ther. 2005 May 15;21(10):1231-9. doi: 10.1111/j.1365-2036.2005.02461.x.
- Background: PubMed 15628711Sander GB, Mazzoleni LE, Francesconi CF, Wortmann AC, Ott EA, Theil A, Da Cruz PV, Da Silva AC, Oliveira L, Beheregaray S, Matioti S, Somm G, Goldim JR. Development and validation of a cross-cultural questionnaire to evaluate nonulcer dyspepsia: the Porto Alegre Dyspeptic Symptoms Questionnaire (PADYQ). Dig Dis Sci. 2004 Nov-Dec;49(11-12):1822-9. doi: 10.1007/s10620-004-9578-z.
- Derived from this study: PubMed 22123802Mazzoleni LE, Sander GB, Francesconi CF, Mazzoleni F, Uchoa DM, De Bona LR, Milbradt TC, Von Reisswitz PS, Berwanger O, Bressel M, Edelweiss MI, Marini SS, Molina CG, Folador L, Lunkes RP, Heck R, Birkhan OA, Spindler BM, Katz N, Colombo Bda S, Guerrieri PP, Renck LB, Grando E, Hocevar de Moura B, Dahmer FD, Rauber J, Prolla JC. Helicobacter pylori eradication in functional dyspepsia: HEROES trial. Arch Intern Med. 2011 Nov 28;171(21):1929-36. doi: 10.1001/archinternmed.2011.533.
- Derived from this study: PubMed 21839884Sander GB, Mazzoleni LE, Francesconi CF, Balbinotto G, Mazzoleni F, Wortmann AC, Cardoso Ide Q, Klamt AL, Milbradt TC; Helicobacter Eradication Relief of Dyspetic Symptoms Trial Investigators. Influence of organic and functional dyspepsia on work productivity: the HEROES-DIP study. Value Health. 2011 Jul-Aug;14(5 Suppl 1):S126-9. doi: 10.1016/j.jval.2011.05.021.
- Official Homepage of Site that is Conducting the StudyLink provided by the sponsor.
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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.
Luiz E Mazzoleni, MD, MsC, PhD principal investigator
Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Carlos F Francesconi, MD, PhD study chair
Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Guilherme B Sander, MD, MsC study chair
Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin, Clarythromycin, Omeprazole for ten days in people with Functional Dyspepsia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 16 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: finished, as of the sponsor's last update on 1 Mar 2018. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire (time frame: the last visit among the antecipated visits (4, 8 and 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00404534, which also lists 5 linked publications.
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 1 Mar 2018.