NCT00404534

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 1, 2018

Status Verified

March 1, 2010

Enrollment Period

2.7 years

First QC Date

November 27, 2006

Last Update Submit

February 27, 2018

Conditions

Functional Dyspepsia

Keywords

functional dyspepsiaHelicobacter pyloriAnti-Inflammatory Agents, Non-SteroidalGastritis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire

    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

    the last visit among the antecipated visits (4, 8 and 12 months)

  • Need of rescue medication

    4, 8 and 12 months

  • Median difference of score between groups

    the last visit among the antecipated visits (4, 8 and 12 months)

  • Mean SF-36 scores evolution between groups

    12 months

  • Lost of productivity measured by WPAI between groups

    12 months

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Amoxicillin 1000 mg BID, clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days

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

Drug: Amoxicillin, Clarythromycin, Omeprazole for ten days

Interventions

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.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with more than 18 years
  • Functional dyspepsia accordingly Rome III criteria
  • Helicobacter pylori infection by two diagnostic tests

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 16416218BACKGROUND

  • 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.

    PMID: 15882244BACKGROUND

  • 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.

    PMID: 15628711BACKGROUND

  • 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.

    PMID: 22123802DERIVED

  • 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.

    PMID: 21839884DERIVED

Related Links

MeSH Terms

Conditions

Gastritis

Interventions

AmoxicillinOmeprazole

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesPyridinesHeterocyclic Compounds, 1-RingBenzimidazoles

Study Officials

  • Luiz E Mazzoleni, MD, MsC, PhD

    Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

  • Carlos F Francesconi, MD, PhD

    Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

    STUDY CHAIR

  • Guilherme B Sander, MD, MsC

    Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 28, 2006

Study Start

October 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 1, 2018

Record last verified: 2010-03

Locations

BR(1)