CTRI/2011/07/001866招募中3 期
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
- 招募中
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Meet criteria for primary JPFS
- •-Have a score of greater than or equal to 4 on BPI average pain severity (Item 3) during screening
- •-Female patients must have a negative serum pregnancy test during screening
- •-Patients parent/legal representative and patient judged to be reliable to keep all appointments for clinical tests and procedures
- •-Patients parent/legal representative and patient must have a degree of understanding such that they can communicate intelligently
- •-Patients must be capable of swallowing investigational product whole
- •-Patients must have venous access sufficient to allow blood sampling and be compliant with blood draws
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- •-Previously completed or withdrawn from this study or any duloxetine study
- •-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 or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (for example, systemic lupus erythematosus)
- •-Have a 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 kg at screening
- •-Changed the type or intensity of psychotherapy within 3 months prior to 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 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
- •-Initiated or discontinued hormone therapy within the previous 3 months
- •-Female patients who are either pregnant, nursing or have recently given birth
研究者
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