Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 29
- 主要终点
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
研究概览
简要总结
The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).
This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device or concurrently enrolled in any other type of medical research
- •Previously completed or withdrawn after randomization from a study investigating duloxetine
- •Known hypersensitivity to duloxetine or any of the inactive ingredients, or have frequent or severe allergic reactions to multiple medications
- •Treated with duloxetine within the last 6 months. Will not likely benefit from duloxetine treatment, in the opinion of the investigator or have had prior nonresponse or inadequate tolerance to duloxetine
- •Pain symptoms related to traumatic injury, past surgery, structural bone or joint disease or regional pain syndrome that will interfere with interpretation of outcome measures
- •Currently have evidence of rheumatologic disorder or have a current diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (for example, systemic lupus erythematosus)
- •Have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I condition, currently or within the past year, except major depressive disorder (MDD) and/or generalized anxiety disorder (GAD), adjustment disorder or specific phobias with primary investigator approval
- •Have a current secondary DSM-IV Axis I condition of attention-deficit/hyperactivity disorder that requires pharmacologic treatment
- •Lifetime DSM-IV Axis I diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
- •DSM-IV Axis II disorder which would interfere with protocol compliance
- •History of substance abuse or dependence within the 6 months
- •Positive urine drug screen for any substances of abuse or excluded medication
- •Family history of 1 or more first-degree relatives with diagnosed bipolar I disorder
- •Significant suicide attempt within 1 year of screening or are currently at suicidal risk in the opinion of the investigator
- •Weight less than 20 kilogram (kg) at screening
- •History of seizure disorder (other than febrile seizures)
- •Taking any excluded medications that cannot be discontinued at screening
- •Fluoxetine within 30 days prior to completion of screening
- •Monoamine oxidase inhibitor (MAOI) within 14 days of screening; or the potential need to use an MAOI during the study or within 5 days of discontinuation of investigational product
- •Abnormal thyroid-stimulating hormone (TSH) concentrations
- •Uncontrolled narrow-angle glaucoma
- •Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C)
- •Serious or unstable medical illness
- •Female participants who are either pregnant, nursing or have recently given birth
研究组 & 干预措施
Duloxetine
Blinded treatment period: 30mg or 60mg once daily for 13 weeks
Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks
Taper period: 30mg Duloxetine or placebo once daily for 1 week.
干预措施: Duloxetine (Drug)
Placebo
Blinded treatment period:Placebo once daily for 13 weeks
Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks
Taper period: 30mg Duloxetine or placebo once daily for 1 week.
干预措施: Duloxetine (Drug)
Placebo
Blinded treatment period:Placebo once daily for 13 weeks
Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks
Taper period: 30mg Duloxetine or placebo once daily for 1 week.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
时间窗: Baseline, 13 weeks
Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means.
次要结局
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items(Baseline, 13 weeks)
- Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item(Baseline (Extension Phase), 39 weeks)
- Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks(13 weeks)
- Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks(13 weeks)
- Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score(Baseline (extension phase), 39 weeks)
- Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score(Baseline (extension phase), 39 weeks)
- Change From Baseline in Functional Disability Inventory Child Form (FDI-child)(Baseline (extension phase), 39 weeks)
- Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores(Baseline (extension phase), 39 weeks)
- Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items(Baseline (extension phase), 39 weeks)
- Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)(Baseline, 13 weeks)
- Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)(Baseline, 13 weeks)
- Change From Baseline in Children's Depression Inventory (CDI)(Baseline (extension phase), 39 weeks)
- Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)(Baseline (extension phase), 39 weeks)
- Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)(Baseline (extension phase), 39 weeks)