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NCT00723502: FLASH
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
Phase 2 trial testing Finafloxacin + Amoxicillin in Gram-Negative Bacterial Infections in 30 participants. Completed in 1 April 2009.
1 April 2009
Quick facts
| Lead sponsor | MerLion Pharmaceuticals GmbH |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 September 2008 |
| Primary completion | 1 April 2009 |
| Estimated completion | 1 April 2009 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Finafloxacin + Amoxicillin — full drug profile →
- Finafloxacin + Esomeprazole — full drug profile →
Conditions studied
- Gram-Negative Bacterial Infections — all drugs for Gram-Negative Bacterial Infections →
- Helicobacter Infections — all drugs for Helicobacter Infections →
- Dyspepsia — all drugs for Dyspepsia →
Sponsor
MerLion Pharmaceuticals GmbH — full company profile →
Who can join
Adults 18 to 70, any sex, with Gram-Negative Bacterial Infections or Helicobacter Infections. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Eradication of Helicobacter pylori
Time frame: 14 days
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Antibacterials with Novel Chemical Scaffolds in Clinical Development.
Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x
Verify or expand the search:
- PubMed search for NCT00723502
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gram-Negative Bacterial Infections
Currently open trials in the same condition.
- NCT06135350 — Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial B · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00723502 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MerLion Pharmaceuticals GmbH
- Last refreshed: 15 June 2009
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00723502.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing