NCT00404534 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Mazzoleni LE, Sander GB, Ott EA, Barros SG, Francesconi CF, Polanczyk CA, Wortmann AC, Theil AL, Fritscher LG, Rivero LF, Cartell A, Edelweiss MI, Uchôa 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.
Ott EA, Mazzoleni LE, Edelweiss MI, Sander GB, Wortmann AC, Theil AL, Somm G, Cartell A, Rivero LF, Uchôa 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.
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.

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

Details for clinical trial NCT00404534

Clinical trial NCT00404534 - References