NCT00813826Unknown2 期
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
Solace Pharmaceuticals0 个研究点目标入组 204 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 204
- 主要终点
- The primary endpoint of this study is the change in a subject's mean pain score from the baseline period to the end of the treatment period as measured using the 11-point Numerical Rating Scale.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain associated with post-herpetic neuralgia (PHN) in recently diagnosed patients.
详细描述
This study will enroll subjects with established PHN, a stable pain intensity and that meet all other eligibility criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 years or older.
- •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.
- •Well established consistent pain during baseline phase.
- •Completed a washout period of 7 days for existing pain medications.
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Pregnant or breast feeding.
- •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.
- •Previous neurolytic or neurosurgical therapy for PHN.
- •Treatment with local anesthetic nerve blocks within the last 30 days.
- •Failure of an adequate dose of 3 or more first line drug treatments for PHN-related pain due to efficacy.
- •Any other type of pain which may impair the self assessment of the pain due to PHN.
- •Skin conditions in the affected dermatome that could alter sensation.
- •Participation in other studies within 30 days before the current study begins and/or during study participation.
- •Taking CYP1A2 inhibitors such as fluvoxamine, certain fluoroquinolones (e.g., ciprofloxacin, enoxacin, pefloxacin, etc), mexiletine, and zileuton.
- •History of drug or alcohol abuse during the last 5 years.
- •Creatinine clearance <50 mL/min.
- •History of malignancy other than basal cell carcinoma and carcinoma in situ.
- •History of chronic hepatitis B or C, or human immunodeficiency virus (HIV) infection.
- •Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease.
- •Immunocompromised state.
- •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.
研究组 & 干预措施
SLC022
Experimental
300mg TID
干预措施: SLC022 (Drug)
SLC022
Experimental
300mg TID
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Matching placebo capsule
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint of this study is the change in a subject's mean pain score from the baseline period to the end of the treatment period as measured using the 11-point Numerical Rating Scale.
时间窗: 7 weeks
次要结局
- Determining the safety and tolerability of SLC022 300 mg TID compared to placebo TID in subjects with PHN by measuring changes in vital signs, ECG, hematology and other laboratory values, and subject-reported adverse events.(7 weeks)
研究者
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