A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
28 мая 2010 г. обновлено: Eli Lilly and Company
Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia
The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older.
Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
530
Фаза
- Фаза 4
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Hato Rey, Пуэрто-Рико, 00918
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ponce, Пуэрто-Рико, 00716
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San Juan, Пуэрто-Рико, 00935
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85050
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Tucson, Arizona, Соединенные Штаты, 85741
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California
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Los Angeles, California, Соединенные Штаты, 90024
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Pasadena, California, Соединенные Штаты, 91105
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Connecticut
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Cromwell, Connecticut, Соединенные Штаты, 06416
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Danbury, Connecticut, Соединенные Штаты, 06810
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Florida
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Bradenton, Florida, Соединенные Штаты, 34208
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Deland, Florida, Соединенные Штаты, 32720
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Fort Myers, Florida, Соединенные Штаты, 33912
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Orlando, Florida, Соединенные Штаты, 32806
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South Miami, Florida, Соединенные Штаты, 33143
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Tampa, Florida, Соединенные Штаты, 33606
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West Palm Beach, Florida, Соединенные Штаты, 33407
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Illinois
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Oak Brook, Illinois, Соединенные Штаты, 60523
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Indiana
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Lafayette, Indiana, Соединенные Штаты, 47905
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kansas
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Prairie Village, Kansas, Соединенные Штаты, 66206
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Maryland
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Rockville, Maryland, Соединенные Штаты, 20852
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Massachusetts
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Belmont, Massachusetts, Соединенные Штаты, 02478
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Fall River, Massachusetts, Соединенные Штаты, 02721
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Newton, Massachusetts, Соединенные Штаты, 02462
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Springfield, Massachusetts, Соединенные Штаты, 01103
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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St Louis, Missouri, Соединенные Штаты, 63141
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New Jersey
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Edison, New Jersey, Соединенные Штаты, 08817
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Piscataway, New Jersey, Соединенные Штаты, 08854
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North Carolina
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Greensboro, North Carolina, Соединенные Штаты, 27408
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45219
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Toledo, Ohio, Соединенные Штаты, 43623
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oregon
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Eugene, Oregon, Соединенные Штаты, 97404
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Portland, Oregon, Соединенные Штаты, 97210
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19107
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South Carolina
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Myrtle Beach, South Carolina, Соединенные Штаты, 29572
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Dallas, Texas, Соединенные Штаты, 75231
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Lake Jackson, Texas, Соединенные Штаты, 77566
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San Antonio, Texas, Соединенные Штаты, 78229
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Waco, Texas, Соединенные Штаты, 76708
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wichita Falls, Texas, Соединенные Штаты, 76309
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Utah
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West Jordan, Utah, Соединенные Штаты, 84088
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Washington
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Bellevue, Washington, Соединенные Штаты, 98007
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Seattle, Washington, Соединенные Штаты, 98104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tacoma, Washington, Соединенные Штаты, 98405
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Wisconsin
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Middleton, Wisconsin, Соединенные Штаты, 53562
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- male or female patients
- aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
- have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
- all females must test negative for pregnancy at the time of enrollment
- have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
Exclusion Criteria:
- have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
- have regional pain syndrome, multiple surgeries or failed back syndrome
- have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
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: Duloxetine
60-120 mg, oral, every day, 12 weeks
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60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).
Другие имена:
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Плацебо Компаратор: Placebo
oral, daily, 12 weeks
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oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient's Global Impressions of Improvement (PGI-I) at Week 12
Временное ограничение: 12 weeks
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The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms.
It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."
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12 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint
Временное ограничение: Baseline, 12 weeks
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BPI is a self-reported form that assesses severity of pain and the interference of pain on function.
There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).
There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Interference scores range from 0 (does not interfere) to 10 (completely interferes).
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Baseline, 12 weeks
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Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint
Временное ограничение: Baseline, 12 weeks
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MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.
Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension.
Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.
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Baseline, 12 weeks
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Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint
Временное ограничение: Baseline, 12 weeks
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BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression.
Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme).
This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial.
The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.
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Baseline, 12 weeks
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Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint
Временное ограничение: Baseline, 12 Weeks
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The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment.
The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
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Baseline, 12 Weeks
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Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint
Временное ограничение: Baseline, 12 weeks
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BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety.
Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme).
This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial.
The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.
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Baseline, 12 weeks
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Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks
Временное ограничение: Baseline, 12 weeks
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The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.
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Baseline, 12 weeks
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Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint
Временное ограничение: Baseline, 12 weeks
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The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being.
Each question is rated 1 = "greater than normal" to 6 = "totally absent".
Total score ranges from 7 to 42.
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Baseline, 12 weeks
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Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint
Временное ограничение: Baseline, 12 weeks
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Likert scales are patient-rated assessments.
Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed.
Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious.
Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered.
Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered.
Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.
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Baseline, 12 weeks
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Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint
Временное ограничение: 12 Weeks
|
Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score.
BPI average pain score assesses the severity of the average pain in the past 24 hours.
The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
|
12 Weeks
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Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint
Временное ограничение: 12 weeks
|
Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score.
BPI average pain score assesses the severity of the average pain in the past 24 hours.
The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
|
12 weeks
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Change From Baseline in Blood Pressure at 12 Week Endpoint
Временное ограничение: Baseline, 12 weeks
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Baseline, 12 weeks
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Change From Baseline in Heart Rate at 12 Week Endpoint
Временное ограничение: Baseline, 12 weeks
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Baseline, 12 weeks
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Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)
Временное ограничение: Baseline through 12 Weeks
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C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Number of patients with suicidal behaviors, ideations, and acts are provided.
Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Suicidal act: a "yes" answer to actual attempt or completed suicide.
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Baseline through 12 Weeks
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Change From Baseline in Weight at 12 Week Endpoint
Временное ограничение: Baseline, 12 weeks
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Baseline, 12 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Mohs R, Mease P, Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. The effect of duloxetine treatment on cognition in patients with fibromyalgia. Psychosom Med. 2012 Jul-Aug;74(6):628-34. doi: 10.1097/PSY.0b013e31825b9855. Epub 2012 Jun 28.
- Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011 Jun 13;13(3):R86. doi: 10.1186/ar3359.
- Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2010 Dec;37(12):2578-86. doi: 10.3899/jrheum.100365. Epub 2010 Sep 15.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 июня 2008 г.
Первичное завершение (Действительный)
1 апреля 2009 г.
Завершение исследования (Действительный)
1 июля 2009 г.
Даты регистрации исследования
Первый отправленный
5 мая 2008 г.
Впервые представлено, что соответствует критериям контроля качества
6 мая 2008 г.
Первый опубликованный (Оценивать)
7 мая 2008 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
24 июня 2010 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
28 мая 2010 г.
Последняя проверка
1 мая 2010 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания нервной системы
- Заболевания опорно-двигательного аппарата
- Ревматические заболевания
- Мышечные заболевания
- Нервно-мышечные заболевания
- Фибромиалгия
- Миофасциальные болевые синдромы
- Физиологические эффекты лекарств
- Нейротрансмиттерные агенты
- Молекулярные механизмы фармакологического действия
- Агенты периферической нервной системы
- Анальгетики
- Агенты сенсорной системы
- Психотропные препараты
- Ингибиторы захвата нейротрансмиттеров
- Модуляторы мембранного транспорта
- Антидепрессанты
- Дофаминовые агенты
- Ингибиторы обратного захвата серотонина и норадреналина
- Дулоксетина гидрохлорид
Другие идентификационные номера исследования
- 12220 (Другой идентификатор: Company Internal)
- F1J-US-HMGB (Другой идентификатор: Eli Lilly and Company)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .