Clinical Trial Results:
Unilateral, open and randomized phase IV study of 2 groups to assess the degree of comfort with simple Emuliquen® in patients undergoing proctological surgery
Summary
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EudraCT number |
2017-002811-33 |
Trial protocol |
ES |
Global end of trial date |
20 Apr 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Jul 2022
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First version publication date |
23 Jul 2022
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Other versions |
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Summary report(s) |
RESUMEN DE RESULTADOS_LAINCO1107 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
LAINCO1107
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
LAINCO S.A.
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Sponsor organisation address |
Avda. Bizet 8-12 , Rubí, Barcelona, Spain,
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Public contact |
Anna Royo, Dynamic, 0034 933511615, a.royo@evidenze.com
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Scientific contact |
Anna Royo, Dynamic, 0034 933511615, a.royo@evidenze.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Oct 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Apr 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Apr 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the degree of comfort that patients experience after undergoing proctological surgery
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Protection of trial subjects |
Study performed folowing good clinical practices and royal decree 190/2015
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Dec 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 110
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Worldwide total number of subjects |
110
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EEA total number of subjects |
110
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
93
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From 65 to 84 years |
17
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Screening of 21 days where inclusion criteria are confirmed. It coincides with the pre-operative period. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group A | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Emuliquen
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral emulsion
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Routes of administration |
Oral use
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Dosage and administration details |
500mg/ml every day at least 4 weeks and a maximum of 5 weeks.
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Arm title
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Group B | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Lactulosa
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
10gr every day for at least 4 weeks and a maximum of 5 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Group A
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group B
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group A
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Reporting group description |
- | ||
Reporting group title |
Group B
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Reporting group description |
- |
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End point title |
intestinal colic episodes | |||||||||||||||
End point description |
The results are presented as number of patients with at least one intestinal colic during all the study.
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End point type |
Primary
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End point timeframe |
All the study, since the first dose until the end of the treatment.
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Notes [1] - Per protocol population [2] - Per protocol population |
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Statistical analysis title |
Chi squared | |||||||||||||||
Comparison groups |
Group A v Group B
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.509 [3] | |||||||||||||||
Method |
Chi-squared | |||||||||||||||
Confidence interval |
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Notes [3] - Statistically non-significant |
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End point title |
flatulence episodes | |||||||||||||||
End point description |
The results are presented as number of patients with at least one intestinal colic
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End point type |
Primary
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End point timeframe |
All the study, since the first dose until the end of the treatment.
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Statistical analysis title |
Fisher | |||||||||||||||
Comparison groups |
Group A v Group B
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Number of subjects included in analysis |
64
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
> 0.999 [4] | |||||||||||||||
Method |
Fisher exact | |||||||||||||||
Confidence interval |
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Notes [4] - statistically non-significant |
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End point title |
degree of effort during defecation | |||||||||||||||
End point description |
The results are presented as number of patients with at least one intestinal colic during all the study.
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End point type |
Secondary
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End point timeframe |
All the study, since the first dose until the end of the treatment.
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Notes [5] - Per protocol population [6] - Per protocol population |
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Statistical analysis title |
Fisher | |||||||||||||||
Comparison groups |
Group B v Group A
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Number of subjects included in analysis |
64
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
> 0.999 | |||||||||||||||
Method |
Fisher exact | |||||||||||||||
Confidence interval |
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End point title |
degree of pain during defecation | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
All the study, since the first dose until the end of the treatment.
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Notes [7] - per protocol population [8] - per protocol population |
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No statistical analyses for this end point |
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End point title |
episodes of diarrhoea | |||||||||||||||
End point description |
The results are presented as number of patients with at least one diarrhea episode during all the study.
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End point type |
Secondary
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End point timeframe |
All the study, since the first dose until the end of the treatment.
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Since signature of informed consent until the last visit of the study.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
Safety population (group A)
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Reporting group description |
- | ||||||||||||||||||||||||||||||
Reporting group title |
Safety population (group B)
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |