NCT00723502

Brief Summary

The primary objective of this study is to compare the H. pylori eradication rates with Finafloxacin in combination with Amoxicillin or Esomeprazole. The secondary objective is to evaluate and compare the safety and tolerability of multiple oral doses of Finafloxacin plus Amoxicillin versus Finafloxacin plus Esomeprazole.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

July 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

June 16, 2009

Status Verified

October 1, 2008

Enrollment Period

7 months

First QC Date

July 25, 2008

Last Update Submit

June 15, 2009

Conditions

Gram-Negative Bacterial InfectionsHelicobacter InfectionsDyspepsia

Keywords

Helicobacter pyloriEradicationDyspepsia

Outcome Measures

Primary Outcomes (1)

  • Eradication of Helicobacter pylori

    14 days

Study Arms (2)

1

EXPERIMENTAL
Drug: Finafloxacin + Amoxicillin

2

EXPERIMENTAL
Drug: Finafloxacin + Esomeprazole

Interventions

Finafloxacin + AmoxicillinDRUG

Finafloxacin, tablets, 400 mg b.i.d. (8 X 50 mg tablets), oral administration; Amoxicillin, tablet 1000 mg b.i.d. (1 X 1000 mg tablet), oral administration

1
Finafloxacin + EsomeprazoleDRUG

Finafloxacin, tablets, 400 mg b.i.d. (8 X 50 mg tablets), oral administration; Esomeprazole, tablet, 40 mg b.i.d. (1 X 40 mg tablet), oral administration

Also known as: Not apllicable
2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients of 18 to 70 years old, with dyspepsia or dyspeptic symptoms.
  • The patient must understand the nature of the study and must provide written informed consent.
  • Each patient must be able to communicate with study personnel.
  • Gastroscopic confirmation of H. pylori infection by Rapid Urease Test.
  • Positive Urea Breath Test.
  • Absence of blood in stools.

You may not qualify if:

  • Gastroscopic confirmation of gastric ulcers.
  • History of Zollinger-Ellison syndrome.
  • Gastroesophageal Reflux Disease (GERD).
  • Subtotal gastrectomy or vagotomy in medical history.
  • Pyloric stenosis.
  • Previous H. pylori eradication therapy.
  • Patients likely to need to take one of the following medication within two weeks prior to and during the study period:
  • any other antibiotic than the study medication;
  • any other proton-pump inhibitor than the study medication;
  • NSAIDs including aspirin and glucocorticoids;
  • Patients taking antacids and/or H2-blockers during the study period.
  • Patients taking bismuth compound within four weeks prior to and during the study period.
  • Patients with psychiatric, neurological, or behavioral disorders that may interfere with the conduct or interpretation of the study.
  • Patients with severe concomitant disease of the cardiovascular, pulmonic, hepatic, renal, hematological, lymphatic, metabolic, and endocrine system.
  • Patients with known uncontrolled hypertension or symptomatic hypotension.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Hein

Marburg, 35037, Germany

Location

MeSH Terms

Conditions

Gram-Negative Bacterial InfectionsHelicobacter InfectionsDyspepsia

Interventions

finafloxacinAmoxicillinEsomeprazole

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOmeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesPyridinesHeterocyclic Compounds, 1-RingBenzimidazoles

Study Officials

  • Peter Malfertheiner, MD, Director

    Not affiliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 28, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

June 16, 2009

Record last verified: 2008-10

Locations

DE(1)