EUCTR2005-004188-50-DE进行中（未招募）不适用
Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 215
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.
- •[2] Present with pain due to bilateral peripheral neuropathy
- •[3] All females must test negative for a pregnancy test at Visit 1. Females of childbearing potential (not surgically sterilized and between menarche and 1 year
- •postmenopause) 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. Examples of reliable methods include use of oral contraceptives or Depo-Provera® Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia & Upjohn), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
- •[4] Score of =4 on the Brief Pain Inventory (BPI) 24-hour average pain item at Visit 2.
- •[5] Education level and degree of understanding such that they can communicate
- •intelligibly with the investigator and study coordinator.
- •[6] Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.
- •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, or are immediate
- •family of investigator site personnel directly affiliated with the study.
- •[8] Are employed by Lilly or Boehringer Ingelheim (BI) (that is, employees, temporary
- •contract workers, or designees responsible for conducting the study).
- •[9] Patients who 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 (Visit 1).
- •[10] Patients who have previously completed or withdrawn from this study or any other
- •study investigating duloxetine or have previously been treated with duloxetine.
- •[11] Are judged at Visit 1 or Visit 2 to be at suicidal risk by the clinical investigator or as
- •defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II
- •[12] History of substance abuse or dependence within the past year, excluding nicotine
- •and caffeine.
- •[13] A positive urine drug screen for any substances of abuse. Note: If the patient has a
- •positive urine drug screen at Visit 1 for an excluded medication that may not have had an
- •adequate washout period, a retest may be performed prior to Visit 2. If the retest is
- •positive for the parent compound, the patient will be excluded.
- •[14] Women who are breast-feeding.
- •[15] Historical exposure to drugs known to cause neuropathy (for example, vincristine),
- •or a history of a medical condition, including pernicious anemia and hypothyroidism, that
- •could have been responsible for neuropathy (see Section 5.7).
- •[16] Pain that cannot be clearly differentiated from or conditions that interfere with the
- •assessment of the diabetic peripheral neuropathy pain.
- •[17] Unstable glycemic control as assessed by a physician investigator and a glycosylated
- •hemoglobin (HbA1c) >12% before Visit 2.
- •[18] Serious or unstable cardiovascular, hepatic, renal, 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.
- •[19] Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
- •[20] Taking any excluded medications that cannot be discontinued at Visit 1.
- •[21] Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit
- •2 or the potential need to take during or within 5 days after discontinuation from the
- •[22] Treatment with fluoxetine within 30 days prior to Visit 2.
- •[23] Known hypersensitivity to duloxetine or any of the inactive ingredients or patients
- •with frequent or severe allergic reactions to multiple medications.
- •[24] Have uncontrolled or poorly controlled hypertension.
- •[25] Have a seizure disorder.
- •[26] Have uncontrolled narrow-angle glaucoma.
研究者
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