NCT00900783已完成2 期
A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir in Patients With Herpes Zoster
Bristol-Myers Squibb0 个研究点目标入组 350 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 主要终点
- Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI)
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of two doses of FV-100 to valacyclovir in patients with herpes zoster, or shingles. FV-100 has shown to be very potent in cells infected with varicella zoster virus, the virus that causes shingles. The study objectives include:
- Compare the safety of FV-100 to valacyclovir
- Compare the effect of FV-100, as compared to valacyclovir, on shingles pain
- Compare the effect of FV-100, as compared to valacyclovir, on shingles lesions
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 50 years of age
- •Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash
- •Patients with zoster-related pain (ZBPI worst pain score > 0)
- •Patients able to be enrolled into the study ≤ 72 hours from appearance of rash (i.e., lesions or vesicles)
- •Patients providing written informed consent
- •Patients who are able to complete all study visits per protocol
- •Men and premenopausal women must agree to practice a barrier method of birth control plus the use of a spermicide for one month after the last dose of study drug (oral contraceptives are not permitted)
排除标准
- •Women who are pregnant or lactating
- •Patients with multidermatomal or disseminated HZ (i.e., > 20 vesicles beyond the dermatomes adjacent to the primarily involved dermatome)
- •Patients with HZ ophthalmicus, defined as cutaneous lesions in the dermatome associated with the ophthalmic division of the trigeminal nerve
- •Patients with history of impaired renal function, (e.g., calculated creatinine clearance <50 mL/min/1.73 m2)
- •Patients taking narcotic analgesic routinely for a chronic pain condition
- •Patients taking tricyclic antidepressants
- •Patients who have received systemic antivirals with activity against VZV within the past 30 days, or a topical antiviral to treat their current HZ
- •Patients who are immunosuppressed from:
- •disease (e.g., malignancy [present or remission < 5 years], HIV)
- •corticosteroid use (except intermittent or topical/inhaled beclomethasone dipropionate or equivalent < 800 mcg/day), or
- •other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation)
- •Patients with gastrointestinal dysfunction that could interfere with drug absorption
- •Patients with any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment) that, in the opinion of the site investigator, might interfere with the evaluations required by the study
- •Patients who are not ambulatory (bed-ridden or homebound); hospitalized patients may be enrolled if they are ambulatory and able to complete the study requirements
- •Patients with history of allergy to valacyclovir hydrochloride
- •Patients unlikely to adhere to protocol follow-up
- •Subjects taking strong CYP3A4-inhibiting protease inhibitors (specifically including atazanavir, indinavir, nelfinavir, saquinavir, and ritonavir), strong CYP3A4 inhibitors (specifically including clarithromycin, itraconazole, ketoconazole, nefazodone, telithromycin) and all strong CYP3A4 inducers (specifically including rifampin, efavirenz, etravirine, phenobarbital, phenytoin, and carbamazepine)
研究组 & 干预措施
2
Experimental
FV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days
干预措施: FV-100 (Drug)
2
Experimental
FV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days
干预措施: Valacyclovir placebo (Drug)
3
Active Comparator
Valacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days
干预措施: valacyclovir (Drug)
3
Active Comparator
Valacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days
干预措施: FV-100 placebo (Drug)
1
Experimental
FV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days
干预措施: FV-100 (Drug)
1
Experimental
FV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days
干预措施: Valacyclovir placebo (Drug)
结局指标
主要结局
Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI)
时间窗: 30 days
次要结局
- Herpes zoster associated pain(90 days)
- Routine clinical labs(30 days)
- Herpes zoster lesion healing(Until healed)
研究者
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