- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00836381
Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder
Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase Ⅳ)
For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB concluded that the drugs provide significant improvements in OAB symptoms compared with placebo but that the benefits are of limited clinical significance. The analysis questioned the clinical significance of the trial results, one reason for which was the lack of data on the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures of treatment success may be meaningful to clinicians but often have little meaning to patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun to recognize the value of PROs but still overlook the treatment efficacy in terms of patient-reported goal achievement (PGA).
Patients with OAB have combination of symptoms and the extent to which individual OAB symptoms affect patients varies. Also each patient can have different goal for the treatment. Therefore, assessing the degree of goal achievement in each patient can provide a new aspect of treatment benefit.
This controlled study will advance the understanding of OAB in terms of patient-centered treatments goals and goal achievement and will provide a new aspect of treatment benefit.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Objectives
- Primary objective: To explore the "Patient-reported Goal Attainment (PGA)" after 12 weeks of treatment with tolterodine extended-release (ER) 4mg in female overactive bladder (OAB) patients.
- Secondary objective: To explore the patient-reported treatment goals and the efficacy of tolterodine on the patient-reported outcomes (PROs), micturition diary parameters, and safety parameters from baseline to 12 weeks of treatment in female OAB patients.
Specific aim
: To compare the efficacy of tolterodine ER 4mg with that of placebo, on PROs in terms of PGA after 12 weeks of treatment in female OAB patients.
Experimental/research design
- 12-week randomized, placebo-controlled, double-blind, parallel-group, prospective study in Korean women with symptoms of OAB
- Treatment: Each patient will receive tolterodine ER (4 mg, qd) or placebo (randomized in the ratio of 1:1) for 12 weeks.
- Time schedule Start date: 01/Jan/2009 Finish date: 01/Sep/2009 Duration of washout: 7 days Duration of run-in: 7 days Duration of enrollment period: 5 months Duration of treatment period: 12 weeks Completion of analysis: 6 weeks
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
-
-
-
Seoul, Корея, Республика
- Samsung Medical Center
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Female aged ≥ 18 and ≤ 80 years
Symptoms of OAB as verified by the screening 3 day micturition diary, defined by:
Mean urinary frequency ≥8 times/24 hours Mean number of urgency episodes ≥ 2 episode/24 hours
- Symptoms of OAB for ≥ 3 months.
- Ability and willingness to correctly complete the micturition diary and questionnaire
- Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
Exclusion Criteria:
- Subjects with stress incontinence or mixed stress/urge incontinence where stress incontinence is the predominant component based on prior history.
- Significant hepatic or renal disease, defined as having twice the upper limit of the reference range for serum concentrations of aspartate amino- transferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine.
- Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- Symptomatic acute urinary tract infection (UTI) during the run-in period
- Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last year
- Diagnosed or suspected interstitial cystitis
- Clinically significant bladder outlet obstruction or poor detrusor function defined by clinical symptoms and investigator's opinion according to local standard of care
- Previous history of major urethral and/or bladder surgery
- History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.
- Subjects with neuropathology that could affect the lower urinary tract or nerve supply
- Patients with marked cystocele or other clinically significant pelvic prolapse.
- Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer
- Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with: Any anticholinergic drugs other than trial drug Any drug treatment for overactive bladder
- On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
- Subjects currently taking tricyclic antidepressants, diuretics or alpha blockers who have not been on a stable dose of these medications for at least one month
- Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not been on a stable dose for at least three months
- Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
- An indwelling catheter or practicing intermittent self-catheterization
- Use of any investigational drug within 1 months preceding the start of the study
- Patients with chronic constipation or history of severe constipation
- Pregnant or nursing women
- Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study start and not agreeing to use such methods during the entire study period and for at least 1 month thereafter *Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy).
- Any other condition which makes the patient unsuitable for inclusion.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Плацебо Компаратор: Плацебо
Плацебо один раз в день
|
Identical Placebo once daily
|
|
Экспериментальный: Tolterodine ER
Tolterodine ER 4mg once daily
|
Tolterodine extended-release (ER) 4mg once daily for 12 weeks
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Percentage of goal attainment using visual analog scale (VAS) at visit 3 and 4
Временное ограничение: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
|
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Assessment of patient-reported treatment goal
Временное ограничение: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
|
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
|
|
Patient-reported outcomes
Временное ограничение: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
|
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
|
|
Micturition diary efficacy parameters
Временное ограничение: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
|
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
|
|
Safety parameters
Временное ограничение: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
|
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
|
Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урологические заболевания
- Заболевания мочевого пузыря
- Симптомы нижних мочевыводящих путей
- Урологические проявления
- Мочевой пузырь, гиперактивность
- Физиологические эффекты лекарств
- Нейротрансмиттерные агенты
- Молекулярные механизмы фармакологического действия
- Мускариновые антагонисты
- Холинергические антагонисты
- Холинергические агенты
- Урологические агенты
- Толтеродин тартрат
Другие идентификационные номера исследования
- 2008-09-006
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