EUCTR2016-002772-27-CZ进行中（未招募）1 期
Efficacy and safety of low doses of trazodone in patients affected by painful diabetic neuropathy: randomized, controlled, pilot study. - Trazodone in PD
Angelini S.p.A.0 个研究点目标入组 120 人开始时间: 2016年12月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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 and female patient of any ethnic origin between 18 and 75 years of age (limits included).
- •2. Patient with painful diabetic symmetric polyneuropathy manifesting with distally distributed neuropathic pain.
- •3. Stable glycemic control with a value of HbA1c = 10% at Screening Visit.
- •4. Pain persisting for at least 3 months.
- •5. Neuropathic pain confirmed by DN4 score = 4 at Screening Visit.
- •6. BPI-SF 24-hour average pain score (item 5) = 4 at Screening Visit and Baseline Visit
- •7. Patient who is currently not receiving treatment for diabetic neuropathic pain or patient who is receiving treatment, with drug/s other than gabapentin, and have completed the required washout.
- •8. Women of childbearing potential must have a negative pregnancy test at Screening Visit and have to agree not to start a pregnancy from the signature of the informed consent up to thirty days after the last administration of the investigational product, using an appropriate birth control method, such as combined estrogen and progestogen containing hormonal contraception (e.g. oral, intravaginal, transdermal), progestogen-only hormonal contraception (e.g. oral, injectable, implantable), intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence.
- •9. Legally capable to give their consent to participate in the study and available to sign and date the written informed consent.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Known hypersensitivity to trazodone or gabapentin or their excipients.
- •2. Other forms of neuropathic pain or non-neuropathic pain (included but not limited to peripheral arterial disease, radiculopathy, mononeuropathy, proximal motor neuropathy, post-operative pain, etc).
- •3. Concomitant treatment with other medications for pain management.
- •4. Concomitant treatment with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, indinavir) or drugs known to prolong QT interval.
- •5. Use of trazodone or gabapentin in the previous 3 months.
- •6. Clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests at Screening Visit that in the opinion of Investigator would compromise patient’s participation in the study.
- •7. Active foot ulcer or previous major limb amputation.
- •8. Myocardial infarction or angioplasty or by-pass graft procedures within the past 6 months.
- •9. Patient with increased risk of Torsade de Pointes (e.g. family history of long QT syndrome) or QTcF value higher than 450 msec (male) and QTcF value higher than 470 msec (female) at Screening Visit.
- •10. Transient ischemic attack or cerebral vascular accident within the past 6 months.
- •11. GFR value < 60 ml/min calculated with MDRD formula.
- •12. Significant liver disease, defined as known active hepatitis or elevated liver enzymes over 3 fold the upper normal limit of laboratory normal ranges.
- •13. Patient with latent or known hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption.
- •14. Positive urine drug screen for CNS active drugs (cocaine, opioids, amphetamines and cannabinoids) a Screening Visit.
- •15. Positive present history of glaucoma.
- •16. Hyperthyroidism, even if pharmacologically corrected.
- •17. Significant mental disorders.
- •18. History of seizure events other than a single childhood febrile seizure.
- •19. History of alcohol or psychoactive substance abuse or addiction.
- •20. Women during pregnancy or lactation period.
- •21. Inability to comply with the protocol requirements, instructions or study-related restrictions (e.g. uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study, etc).
- •22. Subject involved in the conduct of the study (e.g. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel, etc).
- •23. Participation to an interventional clinical trial within 3 months prior to Screening Visit.
研究者
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