NCT00772837

Brief Summary

Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . Many studies have examined the effect of H. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative results. Some studies have shown a significant (although weak) symptomatic improvement after H. pylori eradication, and while other yielding negative results. A recent Cochrane review has comprehensively demonstrated that H.pylori eradication therapy has a small but statistically significant effect in H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may still be cost effective . However it is difficult to reconcile these results in areas with very high prevalence of H. pylori infection such as Pakistan since no such studies have been conducted in developing countries. The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a sustained improvement in symptoms of patients diagnosed with H. pylori associated functional (non-ulcer) dyspepsia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

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

August 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 10, 2009

Status Verified

November 1, 2009

Enrollment Period

2.3 years

First QC Date

October 14, 2008

Last Update Submit

November 9, 2009

Conditions

Functional DyspepsiaHelicobacter Pylori Infection

Keywords

Functional DyspepsiaHelicobacter Pylori eradicationQuality of LifeDyspeptic Symptoms

Outcome Measures

Primary Outcomes (1)

  • Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia

    1 year

Secondary Outcomes (1)

  • To determine whether eradication of Helicobacter Pylori improves the quality of life in patients with Functional Dyspepsia i.Quality of life (QoL) assessment on the basis of SF-36.

    1 year

Study Arms (2)

1.H.Pylori Eradication Group

EXPERIMENTAL

The eradication group will receive triple therapy (omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BID and Amoxycillin 1g BID) for 1 week for the eradication of H. pylori

Drug: Omeprazole + Clarithromycin + Amoxycillin

2.Control Placebo Group

PLACEBO COMPARATOR

The control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week

Drug: Omeprazole + placebo antibiotics

Interventions

Omeprazole + Clarithromycin + AmoxycillinDRUG

Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week

1.H.Pylori Eradication Group
Omeprazole + placebo antibioticsDRUG

omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week

2.Control Placebo Group

Eligibility Criteria

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

You may qualify if:

  • Ambulatory adult males and non-pregnant females.
  • Dyspeptic symptoms for at least 3 months.
  • Normal endoscopic findings.
  • H. Pylori positive on testing.

You may not qualify if:

  • Patients with erosive and non erosive esophagitis.
  • Barrette's esophagus.
  • Duodenal Ulcer, Gastric Ulcer or gastric erosions.
  • Patients with known sensitivity to antibiotics.
  • Patients with severe concomitant systemic disease.
  • Patients with upper GI surgery except cholecystectomy.
  • Females with pregnancy or breast-feeding.
  • Malignancy
  • Alarm symptoms such as bleeding per rectum, hematemesis, and severe weight loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Interventions

OmeprazoleClarithromycinAmoxicillin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingErythromycinMacrolidesPolyketidesLactonesAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmides

Study Officials

  • DR.SHAHAB ABID, MD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 15, 2008

Study Start

August 1, 2006

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

November 10, 2009

Record last verified: 2009-11

Locations

PA(1)