Clinical Trial Results:
MULTICENTRIC RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLIND 2-ARM PIVOTAL STUDY ON EFFICACY AND SAFETY OF ARHAMA®-TINKTUR N IN PATIENS WITH ACUTE DIARRHEA
Summary
|
|
EudraCT number |
2011-001776-19 |
Trial protocol |
DE |
Global end of trial date |
29 Apr 2014
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
25 Nov 2021
|
First version publication date |
25 Nov 2021
|
Other versions |
|
Summary report(s) |
ISR2014 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
2010-19
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
CardioSec Clinical Research GmbH
|
||
Sponsor organisation address |
Dalbergsweg 21, Erfurt, Germany, D-99084
|
||
Public contact |
Project manager, CardioSec Clinical Research GmbH, 0049 36178919740, info@cardiosec.de
|
||
Scientific contact |
Project manager, CardioSec Clinical Research GmbH, 0049 36178919740, info@cardiosec.de
|
||
Sponsor organisation name |
Bombastus-Werke AG
|
||
Sponsor organisation address |
Wilsdruffer Str. 170, Freital, Germany, D-01705
|
||
Public contact |
Mathias Solf, Head of R&D, 0049 3516580354, m.solf@bombastus-werke.de
|
||
Scientific contact |
Mathias Solf, Head of R&D, 0049 3516580354, m.solf@bombastus-werke.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 |
29 Apr 2014
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
29 Apr 2014
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
29 Apr 2014
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
Superiority of oral treatment with Arhama®-Tinktur N (7,5 ml oral per 48 hours) compared to placebo
|
||
Protection of trial subjects |
exclusion of severe cases
|
||
Background therapy |
individual possible, was recorded | ||
Evidence for comparator |
Similar to Verum in colour and taste but without effect | ||
Actual start date of recruitment |
01 Sep 2011
|
||
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: 470
|
||
Worldwide total number of subjects |
470
|
||
EEA total number of subjects |
470
|
||
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) |
447
|
||
From 65 to 84 years |
23
|
||
85 years and over |
0
|
|
||||||||||||||||||||||
Recruitment
|
||||||||||||||||||||||
Recruitment details |
26 investigation partners in Germany were involved. They included patients according to the determined criteria. | |||||||||||||||||||||
Pre-assignment
|
||||||||||||||||||||||
Screening details |
checking diagnosis, Inclusion and exclusion criteria. | |||||||||||||||||||||
Pre-assignment period milestones
|
||||||||||||||||||||||
Number of subjects started |
472 [1] | |||||||||||||||||||||
Intermediate milestone: Number of subjects |
pre assignment: 472
|
|||||||||||||||||||||
Intermediate milestone: Number of subjects |
Randomisation: 472
|
|||||||||||||||||||||
Number of subjects completed |
470 | |||||||||||||||||||||
Pre-assignment subject non-completion reasons
|
||||||||||||||||||||||
Reason: Number of subjects |
Consent withdrawn by subject: 1 | |||||||||||||||||||||
Reason: Number of subjects |
Pregnancy: 1 | |||||||||||||||||||||
Notes [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 472-2=470, this are the real numbers before and after randomisation |
||||||||||||||||||||||
Period 1
|
||||||||||||||||||||||
Period 1 title |
preparation (overall period)
|
|||||||||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||||||||
Blinding used |
Double blind | |||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||
Blinding implementation details |
Verum- / Placebo- Solutions were filled in identical 100-ml- glass bottles. They were individualised with labels with the "randomisation number". The corresponding list of the numbers and relation to the study-arms was unknown to patients and investigators.
|
|||||||||||||||||||||
Arms
|
||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||||||||
Arm title
|
Verum | |||||||||||||||||||||
Arm description |
Dosing of 7.5 ml Verum preparation at initialisation and than in Intervals of 48 h until end of diarrhea | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Arhama-Tinktur N
|
|||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||
Other name |
Verum preparation
|
|||||||||||||||||||||
Pharmaceutical forms |
Oral liquid
|
|||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||
Dosage and administration details |
Dosing of 7.5 ml Verum preparation at initialisation and than in Intervals of 48 h until end of diarrhea
|
|||||||||||||||||||||
Arm title
|
Placebo | |||||||||||||||||||||
Arm description |
Dosing of 7.5 ml Placebo preparation at initialisation and than in Intervals of 48 h until end of diarrhea | |||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||
Investigational medicinal product name |
Placebo
|
|||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||
Other name |
Placebo
|
|||||||||||||||||||||
Pharmaceutical forms |
Oral liquid
|
|||||||||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||||||||
Dosage and administration details |
Placebo
|
|||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
preparation
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis sets
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
PPS
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Patients without distinct protocol deviations
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
FAS
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
all included patients
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Verum
|
||
Reporting group description |
Dosing of 7.5 ml Verum preparation at initialisation and than in Intervals of 48 h until end of diarrhea | ||
Reporting group title |
Placebo
|
||
Reporting group description |
Dosing of 7.5 ml Placebo preparation at initialisation and than in Intervals of 48 h until end of diarrhea | ||
Subject analysis set title |
PPS
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Patients without distinct protocol deviations
|
||
Subject analysis set title |
FAS
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
all included patients
|
|
|||||||||||||
End point title |
duration of diarrhoea | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
15.11.2011 - 04.09.2013
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Duration of diarrhoea | ||||||||||||
Comparison groups |
Verum v Placebo
|
||||||||||||
Number of subjects included in analysis |
470
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
equivalence [1] | ||||||||||||
P-value |
> 0.0038 [2] | ||||||||||||
Method |
Kaplan-Meier-Analyse | ||||||||||||
Confidence interval |
|||||||||||||
Notes [1] - zero-Hypothesis: The Duration of diarrhoea is equal in both study arms. [2] - p=0.067 => the zero-Hypothesis is true |
|
|||||||||||||
End point title |
Duration of diarrhoea (DD) for patients with DD>48h | ||||||||||||
End point description |
for patients with Duration of diarrhoea >48h revealed an benefit for Verum with statistical relevance
|
||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
15.11.2011 - 04.09.2013
|
||||||||||||
|
|||||||||||||
Attachments |
post-hoc-graph |
||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
15.11.2011 - 04.09.2013
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Verum
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 2% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
24 Apr 2012 |
-additional blood sample for the immune subset |
||
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 |