EUCTR2013-005162-20-SI进行中（未招募）1 期
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 in Subjects with Pain Associated with Fibromyalgia
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years
- •2. Able to give written informed consent
- •3. Able to complete subject-reported questionnaires per the investigator’s judgment
- •4. At screening, subjects must meet the 1990 American College of Rheumatology (ACR) criteria for FM, i.e. widespread pain present for at least 3 months and pain in at least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be met:
- •Widespread pain index (WPI) = 7 and symptom severity (SS) scale score = 5, or WPI 3 to 6 and SS scale score = 9
- •Symptoms have been present at a similar level for at least 3 months
- •The subject does not have a disorder that would otherwise explain the pain
- •5. ADPS of = 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to randomization (based on completion of at least 4 daily pain diaries during the 7-day baseline period prior to randomization)
- •6. Subject must have documented evidence of a fundoscopic examination (with pupil dilation) or a scanning laser ophthalmoscopy examination within 12 months prior to screening or at screening.
- •7. Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 958
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1. Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g., severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease within 12 months prior to screening that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability.
- •2. Anticipation of initiation or significant change to normal daily exercise routines or need for ongoing use of concomitant medications or non-pharmacological pain management techniques that may confound assessments of efficacy and/or safety
- •3. Unable to undergo pre-study washout of prohibited concomitant medications
- •4. Subjects who are at risk of suicide as defined by their responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) or in the opinion of the investigator. Note: Patients answering yes” to any of the C-SSRS questions at screening must be excluded. Such patients should be referred immediately to a mental health professional for appropriate evaluation.
- •5. Subjects with current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) interview (Version 6.0) at screening, or who answer yes” to the suicidality question (current or past) on the Major Depressive Episode Module (Module A) or who answer yes” to any question in the Suicidality Module (Module B) are excluded. Subjects with mild to moderate major depression or anxiety disorders are permitted to enroll provided that the investigator assesses the subject as clinically stable and appropriate for entry into the study.
- •6. Any diagnosis of lifetime bipolar disorder or psychotic disorder
- •7. Subjects with pain due to other conditions (e.g., diabetic peripheral neuropathic pain or post-herpetic neuralgia) that in the opinion of the investigator, would confound assessment or self-evaluation of the pain associated with FM.
- •8. Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
- •9. Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year
- •10. Any history of a malignancy other than basal cell carcinoma within the past 5 years
- •11. A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
- •12. Known hypersensitivity to alpha2-delta (a2d) ligands or other components of the study medications. Note: Prior exposure to DS-5565 is allowed, as long as hypersensitivity to DS-5565 was not observed.
- •13. Pregnancy or breast-feeding, or intent to become pregnant during the study period
- •14. Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents.
- •15. Subject is an employee of the study center, an immediate family member* of an employee of the study center or an employee of Daiichi Sankyo, INC Research or any of the study vendors supporting this study. *(spouse, parent, child, or sibling, whether biological or legally adopted)
- •16. Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the stu
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