EUCTR2008-002248-40-DE进行中（未招募）不适用
Effect of Duloxetine 60 mg Once Daily versus Placebo in Patients with Chronic Low Back Pain - HMGC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- 性别
- All
入选标准
- •[1] Male or female outpatients at least 18 years of age with chronic low back
- •pain as their primary painful condition and who have provided informed
- •consent by signing the appropriate informed consent document(s). Patients
- •must be competent and able to give their own informed consent.
- •[2] Based upon medical history, neurological examination and medical records,
- •have low back pain (T-6 or below) present on most days for the preceding
- •6 months or longer and fulfill all disease diagnostic criteria
- •[3] Have a score of >4 on the BPI average pain score at both Visits 1 and 2.
- •[4] Females of child-bearing potential must test negative on a pregnancy test at
- •Visit 1. Females of child-bearing potential must agree to utilize
- •medically acceptable and reliable means of birth control as determined by
- •the investigator during the study and for 1 month following the last dose of
- •the study. Women who are pregnant or breast-feeding may not participate in
- •[5] Have education level and degree of understanding such that they can
- •communicate intelligibly with the investigator and study coordinator.
- •[6] Are judged by the investigator to be reliable and agree to keep all
- •appointments for clinic visits, tests, and procedures required by the protocol
- •and have a valid home address.
- •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
- •[7] Are investigator site personnel directly affiliated with the study and/or are
- •immediate family of investigator site personnel directly affiliated with the
- •[8] Are Lilly employees.
- •[9] Have received treatment within the last 30 days with a drug that has not
- •received regulatory approval for any indication at the time of study entry.
- •[10] Have a history of more than 1 low back surgery.
- •[11] Have a history of low back surgery within 12 months prior to study entry.
- •[12] Have received epidural steroids, facet block, nerve block or other invasive
- •procedures aimed to reduce low back pain within 1 month prior to Visit 1.
- •[13] Have previously completed or withdrawn from this study or any other study
- •investigating duloxetine. Note: patients who have been previously screened
- •for a duloxetine study other than this study and never received study drug will
- •be eligible for this study if they meet all current entry criteria.
- •[14] Completion of the daily electronic diaries for less than 70% of the days
- •between Visit 1 and Visit 2.
- •[15] Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective
- •[16] Have major depressive disorder as determined using depression module of the
- •Mini-International Neuropsychiatric Interview
- •[17] Anticipated by the investigator to require use of nonsteroidal anti-inflammatory
- •drugs and includes acetaminophen and paracetamol, opioid
- •analgesics, or other protocol-excluded medication for the duration of the study
- •[18] Have ongoing or anticipated disability compensation or litigation issues, in the
- •best judgement of the investigator.
- •[19] Have a presence of any factors/conditions, medical or other, that in the
- •judgment of the investigator may interfere with performance of study outcome
- •measures, such as treatment-refractory history.
- •[20] Answer ‘yes’ to either question 4 or question 5 on the Suicidal Ideation portion of the C–SSRS or answer yes to any of the suicide-related behaviors on the
- •Suicidal Behavior portion of the C–SSRS; and the ideation or behavior
- •occurred within the past month.
- •[21] Have a positive urine drug screen for any substances of abuse or excluded
- •[22] Have acute liver injury or severe cirrhosis
- •[23] Have a body mass index (BMI) over 40.
- •[24] Have uncorrected thyroid disease, uncontrolled narrow-angle glaucoma,
- •history of uncontrolled seizures, or uncontrolled or poorly controlled
- •hypertension.
- •[25] Have had previous exposure to duloxetine.
- •[26] Have serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory,
- •or hematologic illness, symptomatic peripheral vascular disease, or other
- •medical condition or psychiatric conditions that, in the opinion of investigator,
- •would compromise participation or be likely to lead to hospitalization during
- •the course of the study.
- •[27] Have known hypersensitivity to duloxetine, to its inactive ingredients, or to
- •multiple other medications.
- •[28] Are taking any excluded medications that cannot be discontinued at Visit 1.
- •[29] Treatment with a monoamine oxidase inhibitor within 14 days of Visit
- •2 or the potential need to use an MAOI during the study or within 5 days of
- •discontinuation of study drug.
- •[30] Are non-ambulatory or require the use of crutches or a walker.
- •[31] Have a history of substance abuse or dependence within the past year,
- •excluding nicotine and caffeine.
- 另有 4 项未显示
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