Clinical Trial Results:
insulin resistance, obesity and gastrointestinal bacteria
Summary
|
|
EudraCT number |
2015-000197-35 |
Trial protocol |
IT |
Global end of trial date |
26 Apr 2023
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
05 Feb 2025
|
First version publication date |
05 Feb 2025
|
Other versions |
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 |
IR-HP-14-01
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
IRCCS Azienda Ospedaliero-Universitaria di Bologna
|
||
Sponsor organisation address |
Via Albertoni, 15, Bologna, Italy, 40138, Bologna, Italy,
|
||
Public contact |
Federico Perna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, +39 3471730707, federicoperna73@gmail.com
|
||
Scientific contact |
Federico Perna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, +39 3471730707, federicoperna73@gmail.com
|
||
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 |
19 Dec 2018
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
19 Dec 2018
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
26 Apr 2023
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
The primary objective of the study was to evaluate the effects of the eradication of Helicobacter pylori, in overweight / obese subjects, using as a pharmacological treatment a 10-day standard therapy (40 mg of pantoprazole, 500 mg of clarithromycin, and 1 g of amoxicillin, each administered twice daily) on insulin resistance, with a interventional prospective randomized, placebo-controlled, double-blind study.
|
||
Protection of trial subjects |
No specific protection measures were required due to the specific treatment protocol.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Nov 2015
|
||
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 |
Italy: 100
|
||
Worldwide total number of subjects |
100
|
||
EEA total number of subjects |
100
|
||
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) |
100
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||
Recruitment details |
- | ||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||
Screening details |
Once provided written informed consent, two hundred patients were screened for Hp infection by stool antigen immunochromatography. The first 40 and 60 infected and non-infected patients respectively were enrolled in the protocol for a total of 100 patients. | ||||||||||||||||||||
Period 1
|
|||||||||||||||||||||
Period 1 title |
Overall trial (overall period)
|
||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||
Arms
|
|||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||
Arm title
|
Group Placebo | ||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||
Investigational medicinal product name |
Rice starch
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Capsule
|
||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||
Dosage and administration details |
3 capsules twice a day for 10 days
|
||||||||||||||||||||
Arm title
|
Group Active Treatment | ||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Pantoprazole
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Capsule
|
||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||
Dosage and administration details |
40 mg twice a day for 10 days
|
||||||||||||||||||||
Investigational medicinal product name |
Clarithromycin
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Capsule
|
||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||
Dosage and administration details |
500 mg twice a day for 10 days
|
||||||||||||||||||||
Investigational medicinal product name |
Amoxicillin
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Capsule
|
||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||
Dosage and administration details |
1g twice a day for 10 days
|
||||||||||||||||||||
Arm title
|
Non treated patients | ||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall trial
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Group Placebo
|
||
Reporting group description |
- | ||
Reporting group title |
Group Active Treatment
|
||
Reporting group description |
- | ||
Reporting group title |
Non treated patients
|
||
Reporting group description |
- |
|
|||||||||||||
End point title |
Improvement of HOMA index | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
6 weeks
|
||||||||||||
|
|||||||||||||
Notes [1] - Endpoint has not been measured because no control visit was performed. |
|||||||||||||
Statistical analysis title |
Statistical differences in metabolic variables | ||||||||||||
Comparison groups |
Group Placebo v Group Active Treatment
|
||||||||||||
Number of subjects included in analysis |
39
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
|
||||||||||||||||
Adverse events information [1]
|
||||||||||||||||
Timeframe for reporting adverse events |
6 weeks
|
|||||||||||||||
Assessment type |
Non-systematic | |||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
18.1
|
|||||||||||||||
Reporting groups
|
||||||||||||||||
Reporting group title |
Group Placebo
|
|||||||||||||||
Reporting group description |
- | |||||||||||||||
Reporting group title |
Group Active Treatment
|
|||||||||||||||
Reporting group description |
- | |||||||||||||||
|
||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0.05% | ||||||||||||||||
|
||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The short period of treatment has not caused any adverse event. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
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 |