Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, And Parallel-Group Study Of Subcutaneous Methylnaltrexone (MOA-728) For The Treatment Of Opioid-Induced Constipation In Adult Subjects
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Subjects received subcutaneous methylnaltrexone (also referred to as MOA-728 or MNTX) or placebo every other day beginning on Day 1 up to a maximum of 7 doses during the 2-week double-blind period.
Inclusion criteria for this study included subjects with advanced illness or subjects with chronic nonmalignant pain. The actual study population included only subjects with cancer-related advanced illness.
All subjects who completed the double-blind treatment phase of this study could elect to receive methylnaltrexone during a 12-week open-label extension study, provided eligibility criteria were met. Subjects who did not continue in the open-label extension study had a follow-up visit 2 weeks after their last dose of test article.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Seoul, Корея, Республика, 137-701
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Seoul, Корея, Республика, 135-710
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Seoul, Корея, Республика, 152-703
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Kyounggi-do
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Koyang-shi, Kyounggi-do, Корея, Республика, 410-719
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Tainan, Тайвань, 70428
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Taipei TOC, Тайвань, 100
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Men and women who are at least 18 years of age, and who have a diagnosis of advanced illness with anticipated life expectancy >= 1 month;
- Is receiving a regular dose of opioids for the control of pain;
- Has a diagnosis of opioid induced constipation;
- Is on a stable laxative regimen.
Exclusion Criteria:
- Has a known or suspected mechanical gastrointestinal obstruction, or any potential non-opioid cause of bowel dysfunction contributed to constipation;
- Has evidence of current fecal impaction;
- Has evidence of active diverticulitis, or peritonitis, or a history of bowel surgery within 30 days before test article administration;
- Has a body weight less than 27 kg
- Has any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Methylnaltrexone double-blind
Methylnaltrexone once every other day.
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Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg. Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments).
Другие имена:
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Плацебо Компаратор: Placebo
Placebo once every other day.
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Subjects received matching placebo injections. Study duration: 2 weeks double-blind period (placebo treatments) followed by 12 weeks open-label extension period (MNTX treatments). |
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Другой: Methylnaltrexone open-label
Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period.
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Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg. Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments).
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After the First Injection.
Временное ограничение: Up to 4 hours after the first injection
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There were 2 co-primary endpoints for this study.
This measurement is the first of the 2 co-primary endpoints.
This endpoint measures the percentage of patients who had an RFBM within 4 hours after the first dose of test article during the double-blind period; data are expressed as percentages of patients for the MNTX and placebo groups.
To qualify as rescue free, the bowel movement could not occur within 6 hours after a rectal intervention (ie, rectal suppository, enema, manual disimpaction).
Note that efficacy results (primary and secondary outcomes) are presented for the double-blind period only.
Therefore, no efficacy results are presented for the open-label period.
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Up to 4 hours after the first injection
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The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After Each Dose During Double-blind Period.
Временное ограничение: Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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This measurement is the second of the 2 co-primary endpoints.
This endpoint measures the percentage of patients who had an RFBM within 4 hours after each dose of test article during the double-blind period; data are expressed as percentages of patients by dose (first, second, third, fourth, etc.) for the MNTX and placebo groups.
The definition of RFBM is described above (see first co-primary endpoint).
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Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Percentage of Injections Resulting in RFBM Within 4 Hours After Test Article Administration.
Временное ограничение: Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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This endpoint measures the percentage of injections resulting in RFBMs within 4 hours after test article administration during the double-blind period.
The percentage of injections resulting in RFBMs is calculated for each patient and then data are expressed as the mean (± standard deviation) percentage for the MNTX and placebo groups.
The definition of RFBM is described above (see first co-primary endpoint).
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Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Директор по исследованиям: Enoch Bortey, Bausch Health Americas, Inc.
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 (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Психические расстройства
- Химически индуцированные расстройства
- Расстройства, связанные с употреблением психоактивных веществ
- Признаки и симптомы, пищеварительный тракт
- Наркотические расстройства
- Запор
- Запор, вызванный опиоидами
- Физиологические эффекты лекарств
- Агенты периферической нервной системы
- Агенты сенсорной системы
- Антагонисты наркотиков
- Метилналтрексон
Другие идентификационные номера исследования
- 3200K1-3361
- B2541004
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