Clinical Trial Results:
Peripheral Histamine 1 receptor blockage in Irritable Bowel Syndrome: multicentric trial
Summary
|
|
EudraCT number |
2013-001199-39 |
Trial protocol |
BE |
Global end of trial date |
02 Nov 2022
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
27 Apr 2025
|
First version publication date |
27 Apr 2025
|
Other versions |
|
Summary report(s) |
Article ebastine vs. placebo |
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 |
MulticenterEbastineIBS
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01908465 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
EC UZ Leuven S-number: S55485 | ||
Sponsors
|
|||
Sponsor organisation name |
UZ Leuven
|
||
Sponsor organisation address |
Herestraat 49, Leuven, Belgium,
|
||
Public contact |
TARGID, KU Leuven, guy.boeckxstaens@kuleuven.be
|
||
Scientific contact |
TARGID, KU Leuven, guy.boeckxstaens@kuleuven.be
|
||
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 |
07 Dec 2022
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
02 Nov 2022
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
Relief of global symptoms of Irritable Bowel Syndrome (IBS), as well as abdominal pain in IBS
|
||
Protection of trial subjects |
In case of troublesome side effects of an allergic reaction to the medicine used, the treatment was stopped immediately.
Every adverse event was reported in the eCRF.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2014
|
||
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 |
Netherlands: 22
|
||
Country: Number of subjects enrolled |
Belgium: 181
|
||
Worldwide total number of subjects |
203
|
||
EEA total number of subjects |
203
|
||
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) |
203
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||||||
Recruitment details |
Patients were recruited from the outpatient clinic of the participating centers. | ||||||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||||||
Screening details |
Inclusion criteria: - Rome III criteria - No organic cause of symptoms - Age 18-65 Exclusion criteria: - IBS constipation predominant - history of coeliakie, lactose-intolerance, ... - medication: anti-histaminics, antidepressants, antipsychotics - symptoms started after operation in abdominal cavity | ||||||||||||||||||||||||
Period 1
|
|||||||||||||||||||||||||
Period 1 title |
Overall baseline period (overall period)
|
||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | ||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||
Arm title
|
Ebastine | ||||||||||||||||||||||||
Arm description |
20 mg ebastine, once daily | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
ebastine
|
||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||
Pharmaceutical forms |
Coated tablet
|
||||||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||||||
Dosage and administration details |
1 tablet/day (around the same time every day), 20mg
|
||||||||||||||||||||||||
Arm title
|
Placebo | ||||||||||||||||||||||||
Arm description |
Placebo, once daily | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
|
||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||
Pharmaceutical forms |
Coated tablet
|
||||||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||||||
Dosage and administration details |
1 tablet per day, around the same time every day
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: One patient was excluded from the baseline period full analysis set because of a diagnosis of bile acid diarrhea (= exclusion) after enrollment. |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ebastine
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
20 mg ebastine, once daily | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Placebo, once daily | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Ebastine
|
||
Reporting group description |
20 mg ebastine, once daily | ||
Reporting group title |
Placebo
|
||
Reporting group description |
Placebo, once daily | ||
Subject analysis set title |
IBS-D/ebastine
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Patients with IBS subtype diarrhea were evaluated for the effect of ebastine on stool consistency
|
||
Subject analysis set title |
IBS-D/placebo
|
||
Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Patients with IBS subtype diarrhea were evaluated for the effect of ebastine on stool consistency
|
|
||||||||||
End point title |
Responder rates for clinical response | |||||||||
End point description |
1. Abdominal pain intensity (API): API was assessed daily using a 10-point Visual Analogue Scale. For each week, an average pain score of the worst abdominal pain per day was calcualated. Then, the change in weekly pain score was calculated from the average pain score recorded during the screening phase (baseline). An API weekly responder is defined as a subject who had a decrease of≥30% compared with baseline.
2. Global Relief of Symptoms (GRS): GRS was assessed weekly using a 6-point scale for 12 weeks during treatment and runout. A subject is considered as a GRS weekly responder if he/
she scores total or considerable relief of symptoms compared with baseline.
A study subject is considered as a weekly clinical responder for a particular week if the subject was both an API and GRS responder. Using this definition, a study subject will be defined as
a ‘clinical responder’ if he/she is a weekly Clinical Responder for at least 6 of the 12 weeks of treatment.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
API was assessed daily, for 12 weeks of treatment and run-out period.
GRS was assessed weekly, for 12 weeks of treatment and run-out period.
|
|||||||||
|
||||||||||
Statistical analysis title |
RD - Clinical response rate FAS | |||||||||
Statistical analysis description |
Response rates and p values were determined using multiple imputation with 100 imputations to account for missing data.
FAS = full analysis set
|
|||||||||
Comparison groups |
Ebastine v Placebo
|
|||||||||
Number of subjects included in analysis |
176
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
equivalence | |||||||||
P-value |
= 0.0471 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
7.7
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
0.2 | |||||||||
upper limit |
15.2 |
|
||||||||||
End point title |
Responder rate for GRS | |||||||||
End point description |
A subject was defined as a GRS responder if he/she reported total or obvious relief of symptoms compared with baseline for at least 6 of the 12 weeks of treatment.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
GRS was assessed weekly, for 12 weeks of treatment and run-out period.
|
|||||||||
|
||||||||||
Statistical analysis title |
RD -Global relief of symptoms response rate FAS | |||||||||
Statistical analysis description |
Response rates and p values were determined using multiple imputation with 100 imputations to account for missing data.
FAS = full analysis set
|
|||||||||
Comparison groups |
Ebastine v Placebo
|
|||||||||
Number of subjects included in analysis |
173
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
equivalence | |||||||||
P-value |
= 0.0715 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
8.2
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
-0.7 | |||||||||
upper limit |
17.1 |
|
||||||||||
End point title |
Responder rate for API | |||||||||
End point description |
An API-responder was defined as a patient who experienced an improvement in weekly average API of ≥30% compared with baseline for at least 6 of the 12 treatment weeks.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
API was assessed daily, for 12 weeks of treatment and run-out period.
|
|||||||||
|
||||||||||
Statistical analysis title |
RD Abdominal pain intensity response rate FAS | |||||||||
Comparison groups |
Ebastine v Placebo
|
|||||||||
Number of subjects included in analysis |
178
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
equivalence | |||||||||
P-value |
= 0.0813 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
22.8
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
-1.4 | |||||||||
upper limit |
24.9 |
|
||||||||||
End point title |
IBS-D clinical responders | |||||||||
End point description |
In line with the primary endpoint, IBS-D clinical responders are defined as subjects that were weekly responders for both stool consistency and API during at least 6 of the 12 treatment weeks.
A subject is considered a weekly responder for stool consistency if he/she experiences a ≥50% reduction in the number of days per week with at least one stool of type 6 or 7 on the BSFS compared with baseline.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Stool consistency was assessed daily for 12 weeks of treatment and run-out period.
|
|||||||||
|
||||||||||
Statistical analysis title |
Stool consistency and API response (IBS-D) | |||||||||
Comparison groups |
IBS-D/placebo v IBS-D/ebastine
|
|||||||||
Number of subjects included in analysis |
121
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
equivalence | |||||||||
P-value |
= 0.1309 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
8.3
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
-2.5 | |||||||||
upper limit |
19 |
|
||||||||||
End point title |
IBS-D Stool consistency responder | |||||||||
End point description |
A subject is considered a weekly responder for stool consistency if he/she experiences a ≥50% reduction in the number of days per week with at least one stool of type 6 or 7 on the BSFS compared with baseline. A subject was a stool consistency responder if the subject was a weekly responder during at least 6 of the 12 treatment weeks.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Stool consistency was assessed daily for 12 weeks of treatment and run-out.
|
|||||||||
|
||||||||||
Statistical analysis title |
Stool consistency response (IBS-D) last 4 weeks | |||||||||
Comparison groups |
IBS-D/ebastine v IBS-D/placebo
|
|||||||||
Number of subjects included in analysis |
119
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
equivalence | |||||||||
P-value |
= 0.8046 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
1.9
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
-13.3 | |||||||||
upper limit |
17.1 |
|
|||||||||||||
End point title |
HADS anxiety score | ||||||||||||
End point description |
Mental health and health-related quality of life questionnaire scores were compared between treatment groups and adjusted for baseline values
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Filled out before and after treatment period (on visit 1 and visit 4)
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Interaction clinical responder and HADS anxiety | ||||||||||||
Statistical analysis description |
responder rates for 6 or more of the 12 treatment weeks for clinical response
|
||||||||||||
Comparison groups |
Ebastine v Placebo
|
||||||||||||
Number of subjects included in analysis |
173
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
equivalence | ||||||||||||
P-value |
= 0.7114 | ||||||||||||
Method |
Regression, Logistic | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
HADS depression score | ||||||||||||
End point description |
Mental health and health-related quality of life questionnaire scores were compared between treatment groups and adjusted for baseline values
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Filled out before and after treatment period (on visit 1 and visit 4)
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Interaction clinical responder - HADS depression | ||||||||||||
Statistical analysis description |
responder rates for 6 or more of the 12 treatment weeks for clinical response
|
||||||||||||
Comparison groups |
Placebo v Ebastine
|
||||||||||||
Number of subjects included in analysis |
174
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
equivalence | ||||||||||||
P-value |
= 0.9146 | ||||||||||||
Method |
Regression, Logistic | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
SF-36 General Health | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Median change between baseline and week 12
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
SF-36 Bodily pain | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Median change between baseline and week 12
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
SF-36 Social functioning | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Median change between baseline and week 12
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
SF-36 Mental health | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Median change between baseline and week 12
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
SF-36 Vitality | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Median change between baseline and week 12
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
SF-36 Role-emotional | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Median change between baseline and week 12
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
SF-36 Role-physical | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Median change between baseline and week 12
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
SF-36 Physical functioning | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Median change between baseline and week 12
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Responder rate for clinical response (3/6) | |||||||||
End point description |
3/6 refers to at least 3 out of the last 6 weeks of the treatment period
|
|||||||||
End point type |
Post-hoc
|
|||||||||
End point timeframe |
API was assessed daily, for 12 weeks of treatment and run-out period.
GRS was assessed weekly, for 12 weeks of treatment and run-out period.
|
|||||||||
|
||||||||||
Statistical analysis title |
RD - clinical responder (3/6) | |||||||||
Comparison groups |
Ebastine v Placebo
|
|||||||||
Number of subjects included in analysis |
176
|
|||||||||
Analysis specification |
Post-hoc
|
|||||||||
Analysis type |
equivalence | |||||||||
P-value |
= 0.0386 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
10.2
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
0.6 | |||||||||
upper limit |
19.8 |
|
||||||||||
End point title |
Responder rate GRS (3/6) | |||||||||
End point description |
3/6 refers to at least 3 out of the last 6 weeks of the treatment period
|
|||||||||
End point type |
Post-hoc
|
|||||||||
End point timeframe |
GRS was assessed weekly, for 12 weeks of treatment and run-out period
|
|||||||||
|
||||||||||
Statistical analysis title |
GRS clinical responder (3/6) | |||||||||
Comparison groups |
Placebo v Ebastine
|
|||||||||
Number of subjects included in analysis |
174
|
|||||||||
Analysis specification |
Post-hoc
|
|||||||||
Analysis type |
equivalence | |||||||||
P-value |
= 0.1748 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
7.5
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
-3.3 | |||||||||
upper limit |
18.2 |
|
||||||||||
End point title |
Responder rate API (3/6) | |||||||||
End point description |
3/6 refers to at least 3 out of the last 6 weeks of the treatment period
|
|||||||||
End point type |
Post-hoc
|
|||||||||
End point timeframe |
API was assessed daily, for 12 weeks of treatment and run-out period.
|
|||||||||
|
||||||||||
Statistical analysis title |
RD - API responder (3/6) | |||||||||
Comparison groups |
Ebastine v Placebo
|
|||||||||
Number of subjects included in analysis |
177
|
|||||||||
Analysis specification |
Post-hoc
|
|||||||||
Analysis type |
equivalence | |||||||||
P-value |
= 0.0378 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
15
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
1 | |||||||||
upper limit |
29 |
|
||||||||||
End point title |
Responder rate stool consistency (3/6) | |||||||||
End point description |
3/6 refers to at least 3 out of the last 6 weeks of the treatment period
|
|||||||||
End point type |
Post-hoc
|
|||||||||
End point timeframe |
Stool consistency was assessed daily for 12 weeks of treatment and run-out period.
|
|||||||||
|
||||||||||
Statistical analysis title |
RD - stool consistency responder (3/6) | |||||||||
Comparison groups |
IBS-D/ebastine v IBS-D/placebo
|
|||||||||
Number of subjects included in analysis |
119
|
|||||||||
Analysis specification |
Post-hoc
|
|||||||||
Analysis type |
equivalence | |||||||||
P-value |
= 0.651 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
3.7
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
-12.7 | |||||||||
upper limit |
20.1 |
|
|||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Every adverse event was reported in the eCRF in a timely manner. In case of a serious adverse event, the coördinating center was informed. In case of AEs leading to death, the ethical committee was also informed.
|
||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
|
||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ebastine
|
||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
16 Jul 2014 |
Adding an advertisement to share on intranet and the notice boards of KULeuven en UZ Leuven. |
||
30 Oct 2015 |
Informing regional general practitioners and recruiting patients from referral by general practitioners. |
||
09 Dec 2016 |
To evaluate whether inflammatory mediators and/or metabolites in urine have a predictive value regarding therapeutic response, a urine sample was taken before and after treatment with the study medication. |
||
01 May 2017 |
Open-label follow up with treatment of patients with 2x20mg of ebastine. After 8 and 12 weeks of treatment, patients were evaluated. |
||
22 Jan 2020 |
Addition of site: ZNA Middelheim Antwerpen |
||
22 Jan 2020 |
Addition of site: AZ Sint-Maarten |
||
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 | |||
Online references |
|||
http://www.ncbi.nlm.nih.gov/pubmed/38191268 |