A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multiple Center, Multiple-Dose Study to Assess the Efficacy and Safety of ZYN002 Administered as a Transdermal Gel to Patients with Knee Pain due to Osteoarthritis

Zynerba Pharmaceuticals Pty Ltd0 个研究点目标入组 320 人开始时间: 2016年8月16日最近更新: 2020年1月13日

适应症

试验速览

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•Eligible participants are those who are aged 40 to 75 years
•- moderate to severe knee pain due to OA, are in general good health
•- body mass index between 18-40 kg /m2
•- able and willing to maintain daily pain and skin diaries, able to read, speak and understand English.
•- Females of childbearing potential must have a negative serum pregnancy test and must agree to use an acceptable method of contraception. Males with a partner of childbearing potential must use an acceptable method of contraception.

•- participants who are allergic/hypersensitive to ZYN002 type products
•- exposed to any investigational drug/device in the last 30 days
•- used cannabis or any CBD or THC-containing products in last 4 weeks
•- change in tobacco products in last 30 days
•- used opioids more than half the days in the last month
•- using any concomitant OA therapies, who have any diseases or conditions that are likely to require changes in drug therapy during the study or interfere with the objectives of the study; who are breastfeeding, who are at risk of suicide; who have Hepatitis or HIV; or who have a history of alcohol or drug abuse.
•- Prohibited medications include: midazolam, oral ketoconazole, fluconazole, nefazadone, rifampin, alfentanil, alfuzosin, amiodarone, cyclosporine, dasatinib, docetaxol, eplerenone, ergotamine, everolimus, fentanyl, halofantrine, irinotecan, lapatinib, levomethadyl, lumefantrine, nilotinib, pimozide, quinidine, ranolazine, sirolimus, tacrolimus, temsirolimus, toremifene, tretinioin, vincristine, vinorelbine, St. John’s Wort, benzodiazepines, and any supplements with anti-inflammatory and/or analgesic properties.

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