EUCTR2008-002108-24-DE进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Tolerability of Oral SLC022 300 mg TID, a Glial Cell Modulating Agent,Versus Placebo in the Treatment of Post Herpetic Neuralgia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 154
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 age 18 years or older.
- •2. A history of cutaneous herpes zoster infection and sustained pain associated with the site of the herpes zoster skin rash for >6 months, after onset of the herpes zoster skin rash.
- •3. Pain intensity score of =4 on an 11-point numerical rating scale for at least 5 of 7 days immediately prior to randomization.
- •4. Mean pain intensity of =4 on an 11-point numerical rating scale during the Baseline Phase.
- •5. Completion of at least 5 out of 7 daily pain reports during the Baseline Phase.
- •6. Completed a washout period of 7 days for any of the following medications: a2-d
- •antagonists (e.g., gabapentin), opiate analgesics, topical lidocaine, anticonvulsants, TCAs, serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine), skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletene, and centrally acting analgesics (dextromethorphan, tramadol).
- •7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •8. A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •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
- •1. Pregnant or breast feeding.
- •2. Female subjects who are not surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least one year, or are not willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method], unless sexually abstinent).
- •3. Previous neurolytic or neurosurgical therapy for PHN.
- •4. Treatment with local anesthetic nerve blocks within the last 30 days.
- •5. Failure of an adequate dose of 3 or more first line drug treatments for PHN-related pain due to efficacy. First line drug treatments include a2-d antagonists (gabapentin or pregabalin), SNRIs (e.g., duloxetine), the 5% lidocaine patch, opioid analgesics, tramadol hydrochloride, and TCAs.
- •6. Any other type of pain which may impair the self assessment of the pain due to PHN.
- •7. Skin conditions in the affected dermatome that could alter sensation.
- •8. Participation in other studies within 30 days before the current study begins and/or during study participation.
- •9. Taking CYP1A2 inhibitors such as fluvoxamine, certain fluoroquinolones (e.g. ciprofloxacin, enoxacin, pefloxacin, etc), mexiletine, and zileuton.
- •10. History of drug or alcohol abuse during the last 5 years.
- •11. Creatinine clearance <50 mL/min.
- •12. History of malignancy (< 5 years since diagnosis) other than basal cell carcinoma and carcinoma in situ.
- •14. History of chronic hepatitis B or C, or human immunodeficiency virus (HIV) infection.
- •15. Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease.
- •16. Immunocompromised state.
- •17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
研究者
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