EUCTR2008-001123-62-GB进行中（未招募）1 期
A PHASE II, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RESPONSE, STUDY TO ASSESS THE CLINICAL BENEFIT OF DROXIDOPA AND DROXIDOPA/CARBIDOPA IN SUBJECTS WITH FIBROMYALGIA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Male or female patients;
- •Aged at least 18 years;
- •Diagnosed with fibromyalgia as defined by the 1990 American College of Rheumatology (ACR) criteria.
- •Have a score between 20mm and 90mm on the Visual Analog Scale for Pain (VAS-P) section of the SF-MPQ at screening and baseline visits
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Currently taking any norepinephrine re-uptake inhibitors;
- •Currently taking tri-cyclic antidepressant medication;
- •Have uncontrolled hypertension; defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >110 mmHg or use of = 2 antihypertensive medications
- •Patients currently taking pregabalin unless they provide written informed consent and agree to discontinue pregabalin use 3 weeks prior to other screening procedures and for the duration of the study
- •Have clinically relevant depression noted as significant by Hamilton Depression Scale (HAM-D);
- •History of known or suspected drug or substance abuse;
- •Women of childbearing potential who are not using a medically accepted contraception;
- •Sexually active males whose partner is a WOCP who do not agree to use condoms for the duration of the study and for 4 weeks after the last dose;
- •Women who are pregnant, breast feeding, or plan to become pregnant during the course of this study;
- •Known or suspected hypersensitivity to the study medication or any of its ingredients;
- •Have in the investigator’s opinion any significant cardiac arrhythmia;
- •Any significant systemic, hepatic, cardiac or renal illness;
- •Diabetes mellitus or insipidus;
- •Have a history of closed angle glaucoma;
- •Have a known or suspected current malignancy. Patients with a history of cancer must be symptom- and treatment-free for at least 5 years prior to randomization, with the exception of patients with non-melanoma, non-invasive skin cancers (such as basal cell carcinoma), who should not have had an intervention or recurrence within one year of starting the study;
- •Patients with known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator’s opinion, affect the absorption of study drug;
- •In the investigator’s opinion, have clinically significant abnormalities on clinical examination or laboratory testing;
- •In the investigator’s opinion, are unable to adequately co-operate because of individual or family situation;
- •In the investigator’s opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia;
- •Are not able or willing to comply with the study requirements for the duration of the study;
- •Have participated in another clinical trial with an investigational agent (including named patient or compassionate use protocol) within 1 month before the start of the study;
- •Previous enrollment in the study.
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