Clinical Trial Results:
A multi-centre clinical trial evaluating patients’ ability to independently and safely use the medicinal product indicated in the treatment of erectile dysfunction
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Summary
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EudraCT number |
2018-002597-41 |
Trial protocol |
PL |
Global end of trial date |
26 Apr 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
10 May 2020
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First version publication date |
10 May 2020
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Other versions |
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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 |
O321
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Adamed Pharma S.A.
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Sponsor organisation address |
Pieńków, ul. Mariana Adamkiewicza 6A, Czosnów, Poland, 05-152
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Public contact |
Coordinating Investigator, Roland Dadej, 48 501516005, urologia@vp.pl
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Scientific contact |
Coordinating Investigator, Roland Dadej, 48 501516005, urologia@vp.pl
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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 |
26 Apr 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Apr 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Apr 2019
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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 |
The primary objective of the study is to assess whether patients using specially designed diagnostic tool can independently make safe decision about whether it is appropriate for them to use or not use sildenafil in dose of 50 mg.
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Protection of trial subjects |
IMP used in the study has Marketing Authorization and is used according to approved SmPC. The only additional diagnostic procedures performed according to study protocol are laboratory blood test and cardiac stress test.
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Background therapy |
Routine care | ||
Evidence for comparator |
Not applicable - the comparator has not been used. | ||
Actual start date of recruitment |
07 Dec 2018
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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 |
Poland: 403
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Worldwide total number of subjects |
403
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EEA total number of subjects |
403
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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) |
292
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From 65 to 84 years |
108
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85 years and over |
3
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Recruitment
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Recruitment details |
Patients recruitment took place from 07 Dec 2018 until 26 Apr 2019. Patients were recruited in clinical sites in Poland. | |||||||||
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Pre-assignment
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Screening details |
No screening procedures applied. Patients who signed informed consent, met all inclusion criteria and none of the exclusion criteria were enrolled into the study. | |||||||||
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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 |
Not applicable
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Not applicable.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Sildenafil 50 mg | |||||||||
Arm description |
Each patient was given a package with 2 tablets of IMP, containing 50 mg sildenail citrate as an active substance (Visit 1). Patients were instructed to use no more than 1 tablet a day and to return for Visit 2 - scheduled within 3 weeks from Visit 1. During visit 2 it was verified: whether patient had used the medication; the patients' perception on efficacy of used medication; whether and what adverse drug reactions had occurred. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Maxon, 50 mg, film-coated tablets
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Not more than one tablet a day.
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Arm title
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Diagnostic tool | |||||||||
Arm description |
All patients enrolled into the study were given diagnostic tool at Visit 1. Each patient was instructed to use diagnostic tool without consulting the physician. The patient's final decision was not revealed to the physician - diagnostic tool was returned in a sealed envelope. After that, the physician performed subjective and objective examination to decide whether it is appropriate for the patient to use sildenafil in dose of 50 mg. Each patient was directed to perform laboratory blood testing. Additionally patients with cardiac disorders were directed to perform cardiac stress test. These procedures were used to further assess coherence of answers given by the patients on selected questions contained in the diagnostic tool with the findings implied by results of these tests. | |||||||||
Arm type |
Observational | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Sildenafil 50 mg
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Reporting group description |
Each patient was given a package with 2 tablets of IMP, containing 50 mg sildenail citrate as an active substance (Visit 1). Patients were instructed to use no more than 1 tablet a day and to return for Visit 2 - scheduled within 3 weeks from Visit 1. During visit 2 it was verified: whether patient had used the medication; the patients' perception on efficacy of used medication; whether and what adverse drug reactions had occurred. | ||
Reporting group title |
Diagnostic tool
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Reporting group description |
All patients enrolled into the study were given diagnostic tool at Visit 1. Each patient was instructed to use diagnostic tool without consulting the physician. The patient's final decision was not revealed to the physician - diagnostic tool was returned in a sealed envelope. After that, the physician performed subjective and objective examination to decide whether it is appropriate for the patient to use sildenafil in dose of 50 mg. Each patient was directed to perform laboratory blood testing. Additionally patients with cardiac disorders were directed to perform cardiac stress test. These procedures were used to further assess coherence of answers given by the patients on selected questions contained in the diagnostic tool with the findings implied by results of these tests. | ||
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End point title |
The proportion of patients who will independently make a safe decision on the possibility of taking sildenafil in dose 50 mg. [1] [2] | ||||||||
End point description |
In the study 97.2 % (379) of patients included in the analysis (390) of primary endpoint had made safe decision based on diagnostic tool. Taking into consideration the confidence interval (95% CI was in the range of 95.0% - 98.4%), the proportion of safe answers was fairly higher than the minimal value specified in the study protocol (i.e. the lower end of CI >80%).
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End point type |
Primary
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End point timeframe |
Visit 1 (after the patient used the diagnostic tool and both patient and investigator made independent decision on patient's possibility of taking sildenafil).
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| 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 the primary endpoint the confidence interval for proportion has been calculated. According to study protocol, the lower end of CI should be over 80%. There was no comparison group. The system requires that for statistical analysis at least 2 Comparison groups are chosen. Otherwise, the full data set cannot be validated positively. Thus, section related to statistical analysis has not been filled. The results of the endpoint have been described in “end point description” and "end point values [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Both arms are analysed independently. There is no comparison between the groups. Therefore, this endpoint refers only to Arm: Diagnostic tool. The section related to statistical analysis has not been filled. The results of the endpoint have been described in “end point description” and "end point values". |
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| No statistical analyses for this end point | |||||||||
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End point title |
The proportion of patients whose decision to take sildenafil in 25 mg or 50 mg dose is coherent with the Investigator's opinion [3] | ||||||||
End point description |
In the study 60% (234) of patients included in the analysis of this endpoint (390) have made decision coherent with decision of investigator (95% CI was within 55.1% - 64.7%). In case of 156 patients (40%) who have given different answer in most cases these answers were safe (even though doctor decided that patient is allowed to take sildenafil, patient based on the diagnostic tool decided either not to take the drug or to take lower dose than is feasible according to physician).
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End point type |
Secondary
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End point timeframe |
Visit 1.
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| Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Both arms are analysed independently. There is no comparison between the groups. Therefore, this endpoint refers only to Arm: Diagnostic tool. As for primary endpoint, the section related to statistical analysis has not been filled. The results of the endpoint have been described in “end point description” and "end point values". |
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| No statistical analyses for this end point | |||||||||
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End point title |
The proportion of patients who will make a decision coherent with the decision indicated by the answers given when using the diagnostic tool. [4] | ||||||||
End point description |
In the study 83.4% (317) of patients taken to the analysis of this endpoint (380) made decision, that was in line with decision indicated by diagnostic tool (95% CI was within 79.4% - 86.8%). Age, education, previous experience with PDE5 inhibitors or whether patient has medical occupation does not seem to affect patient’s compliance with diagnostic tool.
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End point type |
Secondary
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End point timeframe |
Visit 1
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| Notes [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Both arms are analysed independently. There is no comparison between the groups. Therefore, this endpoint refers only to Arm: Diagnostic tool. As for primary endpoint, the section related to statistical analysis has not been filled. The results of the endpoint have been described in “end point description” and "end point values". |
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| No statistical analyses for this end point | |||||||||
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End point title |
For a selected group of patients with cardiac disorders who will receive the IMP, a descriptive analysis will be carried out. [5] | ||||||
End point description |
20 patients with cardiac disorders were given two tablets of medicinal product. Among them 18 patients used both tablets, while 2 patients used only one of given tablets - one of patients due to health concerns related to arrhythmia, second due to lack of efficacy. Finally 17 patients were analysed.
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End point type |
Secondary
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End point timeframe |
From Visit 1 until Visit 2
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| Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Both arms are analysed independently. There is no comparison between the groups. Therefore, this endpoint refers only to Arm: Sildenafil 50 mg. As for primary endpoint, the section related to statistical analysis has not been filled. The results of the endpoint have been described in details in the field “end point description”. |
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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 |
Information regarding AEs were collected throoughout the study i.e. from 07 Dec 2018 until 26 Apr 2019. For individual patient - time from Visit 1 until Visit 2 (the actual maximum time between Visit 1 and Visit 2 was 12 weeks).
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Adverse event reporting additional description |
Safety analysis set included all patients who were given study treatment.
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Assessment type |
Systematic | ||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
Sildenafil 50 mg
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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 | |||
