NCT01089621撤回4 期
An Open-label Feasibility Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of retention
研究概览
简要总结
The purpose of this study is to evaluate the possibility of conducting a larger study in adolescents with fibromyalgia syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Meet criteria for juvenile primary fibromyalgia syndrome as defined by Yunus and Masi.
- •Have a score of greater than or equal to 40mm on item 3 of the Pediatric Pain Questionnaire at screening and treatment baseline.
- •Female patients must have a negative pregnancy test at baseline and must agree to abstain from sexual activity or use a reliable method of birth control.
- •Patients must be capable of swallowing study drug whole.
- •Patients must have venous access sufficient to allow blood sampling and be compliant with blood draws as per the protocol.
排除标准
- •Are 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 are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Have pain symptoms related to traumatic injury, past surgery, structural bone or joint disease (such as osteoarthritis, bursitis, tendonitis), or regional pain syndrome that will interfere with the interpretation of outcome measures.
- •Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease.
- •Have any primary Axis diagnosis OTHER than major depressive disorder (MDD) and/or generalized disorder (GAD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), currently or within the past year. Patients with specific phobias may participate in this study.
- •Have any lifetime DSM-IV Axis I diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
- •Have any DSM-IV Axis II disorder which, in the judgment of the investigator, would interfere with protocol compliance.
- •Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
- •Have a positive urine drug screen for any substances of abuse or excluded medication.
- •Have a family history of 1 or more first-degree relatives (parents or siblings) with diagnosed bipolar I disorder.
- •Have a significant suicide attempt within 1 year of screening or are currently at suicidal risk in the opinion of the investigator.
- •Have a weight less than 20 kg at any screening phase.
- •Have initiated, stopped, or changed the type or intensity of psychotherapy within 3 months prior to screening.
- •Have a history of seizure disorder (other than febrile seizures).
- •Have abnormal thyroid-stimulating hormone (TSH) concentrations. Patients with hypothyroidism who have been treated on a stable dose of thyroid supplement for at least the past 3 months and have medically appropriate TSH concentrations, and are clinically euthyroid may participate in the study.
- •Have acute liver injury or sever cirrhosis.
- •Have previously taken duloxetine.
- •Have a serious or unstable medical illness.
- •Have initiated or discontinued hormone therapy within the previous 3 months.
研究组 & 干预措施
Duloxetine
Experimental
干预措施: Duloxetine (Drug)
结局指标
主要结局
Rate of retention
时间窗: 12 weeks of treatment
Rate of enrollment
时间窗: 6 months of enrollment
次要结局
- Change in score from baseline to endpoint on the Brief Pain Inventory (BPI) modified short form severity(Baseline, 12 weeks)
- Endpoint score of Patient Global Impression of Improvement (PGI-I) scale(12 weeks)
- Change in score from baseline to endpoint on the Children's Depression Inventory (CDI)(Baseline, 12 weeks)
- Change in score from baseline to endpoint on the Multidimensional Anxiety Scale for Children (MASC)(Baseline, 12 weeks)
- Columbia Suicide-Severity Rating Scale (CSSRS)(During 12 weeks of treatment)
- Change in score from baseline to endpoint on the Pediatric Quality of Life Inventory - teen report (PedsQL)(Baseline, 12 weeks)
- Number of patients with treatment emergent abnormal laboratory values(During 12 weeks of treatment)
- Change from baseline to endpoint in height(Baseline, 12 weeks)
- Number of patients with treatment emergent abnormal electrocardiogram(During 12 weeks of treatment)
- Change in score from baseline to endpoint on the Pediatric Pain Questionnaire (PPQ)(Baseline, 12 weeks)
- Change in score from baseline to endpoint on the Clinical Global Impression of Severity, overall (CGI-Severity: overall) scale(Baseline, 12 weeks)
- Change in score from baseline to endpoint on the Clinical Global Impression of Severity for Mental Illness (CGI-mental illness) scale(Baseline, 12 weeks)
- Change from baseline to endpoint in blood pressure(Baseline, 12 weeks)
- Change from baseline to endpoint in weight(Baseline, 12 weeks)
- Change in score from baseline to endpoint on the Functional Disability Inventory - parent version (FDI-parent) scale(Baseline, 12 weeks)
- Change from baseline to endpoint in heart rate(Baseline, 12 weeks)
- Change in score from baseline to endpoint on the Functional Disability Inventory - child version (FDI-child) scale(Baseline, 12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety DisorderIrritable Bowel SyndromeGeneralized Anxiety DisorderNCT00961298West Penn Allegheny Health System17
已完成
3 期
An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)Osteoarthritis of the KneeNCT02335346Eli Lilly and Company93
已完成
3 期
Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major DepressionMajor Depressive DisorderNCT00042562Eli Lilly and Company
已完成
1 期
A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy SubjectsHealthyNCT00933452Shanghai Mental Health Center36
已完成
3 期
An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)FibromyalgiaNCT01621191Eli Lilly and Company149