ACTRN12610000603011终止3 期
A Double-blind, Randomised, Placebo-controlled, Flexible-dose of 50 mg/day to 400 mg/day, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel XR) as an Add-on Therapy in Patients with Chronic Somatoform Pain Disorder
Dr Peter Farnbach0 个研究点目标入组 58 人开始时间: 2010年7月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Provision of written and informed consent prior to initiating any study related procedures.
- •2. Male and female aged 18 to 65 years, inclusive.
- •3. Documented clinical diagnosis meeting criteria from the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) for 307.89 Chronic (Somatoform) Pain Disorder associated with both Psychological Factors and General Medical Condition.
- •4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (hCG) pregnancy test at enrolment.
- •5. Patients who have been on stable doses of non-opioid analgesic/s, Non-steroidal anti-inflammatory drugs (NSAIDs) with/or without an antidepressant (excluding fluvoxamine), for at least 6 weeks.
- •6. Be able to understand and comply with the requirements of the study, as judged by the investigator.
- •7. Clinical diagnosis of one or more of the following spine structure problems: facet joints, spinal stenosis, paraspinal muscles, sacroiliac joint, spondylolysis/spondylolisthesis, nonspecific back pain and diskogenic.
排除标准
- •1. Current or past history of: manic, hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV-TR).
- •2. Presence or history of a clinically significant neurological disorder (Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, Huntington’s disease, epilepsy etc.).
- •3. Pregnancy or lactation.
- •4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
- •5. Known intolerance or lack of response to quetiapine fumarate as judged by the investigator.
- •6. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir.
- •7. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids .
- •8. Administration of a depot antipsychotic injection within two dosing interval before randomisation.
- •9. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria.
- •10. Medical conditions that would affect absorption, and metabolism, or excretion of study medication (e.g., malabsorption syndrome, liver disease).
- •11. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator.
- •12. Involvement in the planning and conduct of the study.
- •13. Previous enrolment or randomisation of treatment in the present study.
- •14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.
- •15. A patient with diabetes mellitus (DM) fulfilling one of the following criteria:
- •Unstable DM defined as enrolment glycosylated haemoglobin (HbA1c) > 8.5%;
- •Admitted to hospital for treatment of DM or DM related illness in past 12 weeks;
- •Not under physician care for DM;
- •Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled;
- •Physician responsible for patient’s DM care has not approved patient’s participation in the study;
- •Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks; and
- •Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks.
- •Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- •16. An absolute neutrophil count (ANC) of less than or equal to 1.5 x 109 per litre.
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