drugset / Trial / NCT00404534
Helicobacter Eradication Relief of Dyspeptic Symptoms
Phase 3
Completed
407 enrolled
Hospital de Clinicas de Porto Alegre
Aché Laboratórios Farmacêuticos Ltda · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2006-10
- Primary completion
- 2009-06
- Completion
- 2009-06
Publications
- Background 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.
- Background 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.
- Background 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 1000 mg | — |
| Subject | Clarithromycin | Small molecule | 500 mg | — |
| Background | Omeprazole | Other / unclassified | 20 mg | — |