Gram-Negative Bacterial InfectionsPhase 2FLASHNCT00723502
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
A Phase 2 study testing Finafloxacin + Amoxicillin and Finafloxacin + Esomeprazole in people with Gram-Negative Bacterial Infections and Helicobacter Infections, run by MerLion Pharmaceuticals GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gram-Negative Bacterial Infections, Helicobacter Infections, Dyspepsia
- What is being tested?
- Finafloxacin + Amoxicillin and Finafloxacin + Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Clinically significant serious unstable physical illness: treated, controlled and thus stable hypertension is not considered an exclusion criterion.
- Patients with known uncontrolled hypertension or symptomatic hypotension.
- Patients who are immunocompromised.
- Patients with malignant disease of any kind except Basalioma.
- Patients showing clinically significant abnormal vital signs.
- Patients with clinically significant abnormal ECG findings.
- Clinically significant abnormal laboratory data at Screening, or any abnormal laboratory value that could interfere with the assessment of safety.
- Exposure to any investigational drug within 30 days prior Screening.
- Known hypersensitivity or contraindication to the use of fluoroquinolones.
- Prior participation in Finafloxacin study.
- Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study, e.g. oral (stable doses for at least three months prior to Screening) or injectable (stable doses for at least two months prior to Screening) contraceptives, implantation of levonorgestrel system and intrauterine devices (for at least two months prior Screening), barrier methods (combination of diaphragm and spermicide or condom and spermicide).
- Current diagnosis or known history of substance abuse.
- Site personnel and their immediate families, defined as their spouse, parent, child, grandparent, or grandchild.
- Reasonable likelihood for non-compliance with the protocol or any other reason that, in the investigator's opinion, prohibits the inclusion of the patient into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Multicenter, Two-Arms Efficacy and Safety Study of 14 Days Treatment With Finafloxacin 400 mg b.i.d. Plus Amoxicillin 1000 mg b.i.d.Versus Finafloxacin 400 mg b.i.d. Plus Esomeprazole 40 mg b.i.d. in Patients With Helicobacter Pylori Infection
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.
- Being tested
- Finafloxacin + Amoxicillin, Finafloxacin + Esomeprazole
- Keywords
- Helicobacter pylori, Eradication, Dyspepsia
- Medical subject headings
- Gram-Negative Bacterial Infections, Helicobacter Infections, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Finafloxacin + EsomeprazoleDrug
Also called Not apllicable
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Finafloxacin + Amoxicillin |
| 2 | Experimental | Not described Receives: Drug: Finafloxacin + Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of Helicobacter pylori
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Negative Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MerLion Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Malfertheiner, MD, Director, Principal investigator, Not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723502
- Sponsor's protocol ID
- FINA-002
- Acronym
- FLASH
- Status last verified
- Oct 2008
- First submitted
- 25 Jul 2008
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multicenter, Two-Arms Efficacy and Safety Study of 14 Days Treatment With Finafloxacin 400 mg b.i.d. Plus Amoxicillin 1000 mg b.i.d.Versus Finafloxacin 400 mg b.i.d. Plus Esomeprazole 40 mg b.i.d. in Patients With Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT00723502
- Acronym / sponsor ID
- FLASH / FINA-002
- Keywords
- Helicobacter pylori, Eradication, Dyspepsia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MerLion Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Finafloxacin + Amoxicillin |
| 2 | Experimental | Drug: Finafloxacin + Esomeprazole |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (28 listed)
- Gastroscopic confirmation of gastric ulcers.
- History of Zollinger-Ellison syndrome.
- Gastroesophageal Reflux Disease (GERD).
- Subtotal gastrectomy or vagotomy in medical history.
- Pyloric stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finafloxacin + AmoxicillinFinafloxacin, 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 | Drug | 1 |
| Finafloxacin + EsomeprazoleAlso: Not apllicableFinafloxacin, 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 | Drug | 2 |
Primary outcome
Eradication of Helicobacter pylori
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Malfertheiner, MD, Director principal investigator
Not affiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finafloxacin + Amoxicillin and Finafloxacin + Esomeprazole in people with Gram-Negative Bacterial Infections and Helicobacter Infections, run by MerLion Pharmaceuticals GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of Helicobacter pylori (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2009.