EUCTR2010-020977-18-DE进行中（未招募）不适用
A Multicenter, Double-blind, Randomized, Placebo-controlled, Repeat Treatment (two cycle) Study of the Safety and Efficacy of AGN-214868 in Patients with Postherpetic Neuralgia
Allergan Ltd0 个研究点目标入组 280 人开始时间: 2010年8月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
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. Written informed consent has been obtained. 2. Written Authorization for Use and Release of Health and Research Study Information (US sites only) and written Data Protection consent (EU sites only) has been obtained. 3. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable. 4. Male or female, 18 to 80 years of age inclusive. Females must be of non reproductive potential 5. Males must agree for the duration of the study to use a condom during sexual intercourse with female partners who are of reproductive potential and to have their female partners use an additional effective means of contraception (eg, diaphragm plus spermicide or oral contraceptive), or the male patient must agree to abstain from sexual intercourse. 6. Females considered of non-reproductive potential are defined as females who are post-menopausal (women = 47 years of age who have been amenorrheic for at least 12 consecutive months), or females who do not have a uterus. Females with bilateral tubal ligation and/or both ovaries removed can also be entered into the study. 7. Clinically acceptable laboratory test results at screening (visit 1) 8. Patient has persistent PHN with pain present for at least 9 months after the onset of a herpes zoster skin rash affecting the cervical, thoracic, lumbar, or sacral dermatomes. 9. A maximal area of spontaneous pain that is less than or equal to 250 cm2 at screening 10. A stable dose of no more than one chronic pain drug that belongs to the following classes: 1) antiepileptic drugs, 2) antidepressant drugs, or 3) chronic opioids not to exceed 120 mg morphine equivalent per day at screening. Administration of drugs for conditions other than chronic pain (eg, epilepsy, depression), which can also reduce chronic neuropathic pain should be considered a pain medication. Patients on no chronic pain medication are acceptable 11. Stable chronic dose of pain medication, if any, for at least 28 days prior to the baseline period 12. Willing and able to stay on current chronic pain medication during the course of the study 13. Ability to follow study instructions and likely to complete all required visits and assessments 14. Average pain rating for the past week of at least 4 on the 0 to 10 numerical rating scale (NRS) at screening 15. Satisfactorily completed diary information on at least 4 out of 7 diary entries from day -7 to day -1 16. Average pain intensity score of at least 4 on the NRS (0 to 10 point numerical rating scale) during the baseline period (ie, days -7 to -1)
- •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. Uncontrolled systemic disease other than PHN 2. Female patients with reproductive potential (see Inclusion Criterion 6 for the definition of reproductive potential) 3. Evidence of active liver disease or abnormal liver function tests. Liver function tests above 1.5 times normal must be approved by the medical monitor. 4. Neuropathic pain other than that related to PHN 5. PHN affecting the trigeminal areas or the scalp 6. Other severe pain that may potentially confound PHN pain assessment in the opinion of the investigator 7. Moderate to severe depression (Beck Depression Inventory-II > 19) 8. Active herpes zoster skin rash 9. Previous neurolytic or neurosurgical therapy for PHN 10. Failed to respond (ie, no reduction in pain) to 2 or more classes of treatment for PHN (eg, antiepileptics, antidepressants, opioids) 11. Current (within 30 days) or anticipated treatment with acupuncture, TNS, trigger point injection, or oral and parenteral steroids 12. Current or anticipated use of topical analgesic agents (eg, lidocaine patch within 30 days, or capsaicin cream within 6 months) for PHN 13. Anticipated need for alteration of existing chronic pain medication dosage during the study 14. Current or anticipated need for botulinum toxin therapy of any serotype for any condition, or immunization to any botulinum toxin serotype 15. Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks before screening 16. History of treatment of the area of PHN with high dose capsaicin patch (8% capsaicin) in the prior 6 months 17. Currently on doses of chronic opioids in excess of 120 mg per day of morphine equivalent 18. Known allergy or sensitivity to the study medication or its components 19. Known history of HIV infection and/or HIV sero-positive 20. Abnormal screening laboratory results for hepatitis B surface antigen, hepatitis C antibodies 21. Treatment for, and/or evidence of, alcohol or drug abuse within the past year 22. Is currently enrolled in a trial of an investigational drug or device, or has received any investigational drug within 60 days before the baseline period, or at least 5 elimination half-lives (whichever is longer) 23. Patient has a maximal area of spontaneous PHN pain greater than 250 cm2 (ie, requires more than 65 injections to treat the area(s) of PHN spontaneous pain). 24. Patient has an area of spontaneous PHN pain in the cervical dermatome that extends above the hairline. 25. Evidence of active skin infection or inflammation at the anticipated injection site 26. Patient has a medical condition, or is in a situation, which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
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