Clinical trial NCT00404534: Helicobacter Eradication Relief of Dyspeptic Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Dyspepsia
Keywords: functional dyspepsia
Helicobacter pylori
Anti-Inflammatory Agents, Non-Steroidal
Gastritis
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Aché Laboratórios Farmacêuticos Ltda
First posted: 2006-11-28
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
timeFrame: the last visit among the antecipated visits (4, 8 and 12 months)
Secondary outcomes:
measure: Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
timeFrame: the last visit among the antecipated visits (4, 8 and 12 months)
measure: Need of rescue medication
timeFrame: 4, 8 and 12 months
measure: Median difference of score between groups
timeFrame: the last visit among the antecipated visits (4, 8 and 12 months)
measure: Mean SF-36 scores evolution between groups
timeFrame: 12 months
measure: Lost of productivity measured by WPAI between groups
timeFrame: 12 months
measure: Adverse Events
timeFrame: 4 , 8 and 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
name: Luiz E Mazzoleni, MD, MsC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
name: Carlos F Francesconi, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
name: Guilherme B Sander, MD, MsC
role: STUDY_CHAIR
References:
citation: 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.
citation: Ott 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.
citation: Sander 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.
citation: Mazzoleni 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.
citation: Sander 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.