E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stress urinary incontinence (SUI) in female patients of moderate severity (Grade 2 and Grade 3) |
Стрес уринарна инконтиненция (SUI) при жени – пациентки с умерена степен на тежест (степен 2 и степен 3) |
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E.1.1.1 | Medical condition in easily understood language |
Stress urinary incontinence (SUI) in female patients of moderate severity (Grade 2 and Grade 3). |
Стрес уринарна инконтиненция (SUI) при жени – пациентки с умерена степен на тежест (степен 2 и степен 3) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066218 |
E.1.2 | Term | Stress urinary incontinence |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To show the long term efficacy and safety of the skeletal muscle-derived cell therapy |
Илюстриране на дългосрочната ефикасност и безопасност на терапията чрез имплантация на клетки от скелетно-мускулна тъкан. |
|
E.2.2 | Secondary objectives of the trial |
not applicable |
неприложимо |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients who participated in the phase II study IC-01-01-04-003 “SUITE”,
2. Written informed consent
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1. Пациентките, които са участвали в клиничното изпитване на фаза II - IC-01-01-04-003 “SUITE” и са преминали терапията с имплантиране на клетки (лечение aSMDC на стрес уринарна инконтиненция),
2. Писмено информирано съгласие
|
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E.4 | Principal exclusion criteria |
1. Evidence of uncooperative attitude,
2. Patients who, according to the clinical judgment of the investigator, are not suitable for this study
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1. Доказателство за нагласа на неотзивчивост, неспазване на протокола
2. Пациентки, които съгласно клиничната преценка на Изследователя не са подходящи за това изпитване
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in the Incontinence Episode Frequency (IEF) score compared to pre-treatment baseline measured in predecessor phase II study IC-01-01-04-003 “SUITE” |
Промяна в скалата за Честотата на Епизодите на Инконтиненция (IEF) в сравнение с записаните изходни данни в предишното проучване фаза II - IC-01-01-04-003 “SUITE” |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The study includes two visits (visit 1 and visit 2, minimum one week after visit 1). Period per patie: 1 week |
Клиничното изпитване включва две посещения (посещение 1 и посещение 2, минимум 1 седмица след първото посещение 1)
Период за пациент: 1 седмица |
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E.5.2 | Secondary end point(s) |
Efficacy variables
• I-QoL score,
• VAS score,
• Examinations based on the micturition diary records,
• Investigator’s assessment by CGI score,
• Patient’s assessment by PGI
Safety variables
• Adverse events,
• Safety laboratory measurements, vital signs, physical examinations.
|
Променливи на ефективността
• Скала на подобрение – качеството на живот – I-QoL,
• Скала на ВАС,
• Изследвания въз основа на записите от дневника за уриниране,
• Оценка на Изследователя по скалата на общата клинична оценка – подобрение - CGI
• Оценка на пациента по скалата на общото впечатление на пациента за подобрение - PGI
Променливи на безопасността
• Нежелани събития,
• Лабораторни измервания на безопасността, жизнените показатели, физикални прегледи |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The study includes two visits (visit 1 and visit 2, minimum one week after visit 1). Period per patient: 1 week |
Клиничното изпитване включва две посещения (посещение 1 и посещение 2, минимум 1 седмица след първото посещение 1)
Период за пациент: 1 седмица |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
дългосрочно проследяващо проучване |
long-term follow-up study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
последна визита на последен пациент |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |