Clinical Trial Results:
An open-label, randomized, multicenter, two-arm 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 Finafloxacin in patients with Helicobacter: FLASH study

Trial information Top of page
Trial identification
Sponsor protocol code	FINA-002
Additional study identifiers
ISRCTN number	-
US NCT number	NCT00723502
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	MerLion Pharmaceuticals GmbH
Sponsor organisation address	Robert-Roessle-Str. 10, Berlin, Germany, 13125
Public contact	Head Regulatory Affairs, MerLion Pharmaceuticals GmbH, lueckermann@merlionpharma.de
Scientific contact	Head Regulatory Affairs, MerLion Pharmaceuticals GmbH, lueckermann@merlionpharma.de
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	26 Jun 2009
Is this the analysis of the primary completion data?	Yes
Primary completion date	19 Dec 2008
Global end of trial reached?	Yes
Global end of trial date	19 Dec 2008
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	The primary objective of this study was to compare the H. pylori eradication rates of 14-day treatment with finafloxacin in combination with amoxicillin or esomeprazole.
Protection of trial subjects	Exclusion of subjects showing clinically significant abnormal vital signs or laboratory data at screening.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	28 Aug 2008
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Germany: 30
Worldwide total number of subjects	30
EEA total number of subjects	30
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	24
From 65 to 84 years	6
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	Screening includes after signing of informed consent form Urea Breath Test and gastroscopy for performing Rapid Urea Test.
Period 1
Period 1 title	Overall Trial (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Not blinded
Blinding implementation details	No blinding was performed, as this was an open-label study.
Arms
Are arms mutually exclusive	Yes
Arm title	Finafloxacin/Amoxicillin
Arm description	Finafloxacin twice daily + Amoxicillin twice daily
Arm type	Experimental
Investigational medicinal product name	Finafloxacin hydrochloride
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	400 mg twice daily [b.i.d. (8 X 50 mg tablets)] immediately after meal
Investigational medicinal product name	Amoxicillin
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	1000 mg b.i.d. (as one 1000 mg tablet) immediately after meal.
Arm title	Finafloxacin/Esomeprazole
Arm description	Finafloxain twice daily + Esomeprazole twice daily
Arm type	Experimental
Investigational medicinal product name	Finafloxacin hydrochloride
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	400 mg twice daily [b.i.d. (8 X 50 mg tablets)] immediately after meal
Investigational medicinal product name	Esomeprazole
Investigational medicinal product code
Other name
Pharmaceutical forms	Gastro-resistant tablet
Routes of administration	Oral use
Dosage and administration details	40 mg b.i.d. (as one 40 mg tablet) at least one hour before meal
Number of subjects in period 1 Finafloxacin/Amoxicillin Finafloxacin/Esomeprazole Started 15 15 Completed 15 15

Subject disposition Top of page

Baseline characteristics Top of page

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Finafloxacin/Amoxicillin
Reporting group description	Finafloxacin twice daily + Amoxicillin twice daily
Reporting group title	Finafloxacin/Esomeprazole
Reporting group description	Finafloxain twice daily + Esomeprazole twice daily

End points Top of page

Primary: Efficacy - Eradication H. pylori Top of page
End point title	Efficacy - Eradication H. pylori [1]
End point description	The primary efficacy endpoint was the H. pylori eradication rate at Visit 4 (Day 45) in the finafloxacin plus amoxicillin and finafloxacin plus esomeprazole treatment groups after a 14 day treatment period.
End point type	Primary
End point timeframe	Treatment start to day 45
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: For both treatment groups, the H. pylori eradication rates were determined and also the respective 90% and 95% two-sided confidence intervals. Additionally, the difference in H. pylori eradication rates was estimated and the respective 90% and 95% two-sided confidence interval was determined in order to get an impression of a possible difference in rates.As this is a proof-of-concept study, all results were interpreted in an exploratory sense to get evidence of the H. pylori eradication rates.
End point values Finafloxacin/Amoxicillin Finafloxacin/Esomeprazole Number of subjects analysed 15 15 Units: percent     number (confidence interval 95%) 26.7 (4.3 to 49) 60 (35.2 to 84.4)
No statistical analyses for this end point

Primary: Efficacy - Eradication H. pylori Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Treatment start (day 1) to day 45 - 52
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	11.1
Reporting groups
Reporting group title	Verum
Reporting group description	-
Serious adverse events Verum Total subjects affected by serious adverse events      subjects affected / exposed 1 / 30 (3.33%)      number of deaths (all causes) 0      number of deaths resulting from adverse events 0 Infections and infestations Oophoritis      subjects affected / exposed 1 / 30 (3.33%)      occurrences causally related to treatment / all 0 / 1      deaths causally related to treatment / all 0 / 0
Frequency threshold for reporting non-serious adverse events: 2%
Non-serious adverse events Verum Total subjects affected by non serious adverse events      subjects affected / exposed 24 / 30 (80.00%) General disorders and administration site conditions Fatigue      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Ear and labyrinth disorders Tinnitus      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Gastrointestinal disorders Anal pruritus      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Burning mouth syndrome      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Constipation      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Diarrhoea      subjects affected / exposed 8 / 30 (26.67%)      occurrences all number 8 Dyspepsia      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Flatulence      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Gastrooesophageal reflux disease      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Tongue disorder      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Reproductive system and breast disorders Vulvovaginal pruritus      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Skin and subcutaneous tissue disorders Pruritus      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Rash      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Infections and infestations Nasopharyngitis      subjects affected / exposed 2 / 30 (6.67%)      occurrences all number 2 Oral candidiasis      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Vaginal infection      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
27 Aug 2008	Shelf life extension
01 Sep 2008	Correction of numbers of biopsy samples.
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

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