None listed
Conditions
Brief summary
This study aims to investigate the effectiveness and safety of twice daily ZYN002, for 12 weeks in 320 (300 randomized) adults with knee pain due to osteoarthritis of the knee. This will be done by analysing a daily pain score and skin check, knee pain and rescue medication diary, and side effects. Safety will be monitored during the treatment visits using standard measures, including physical and neurological exams, vital signs (including oral temperature), 12-lead ECGs, clinical laboratory tests and side effect monitoring. Skin at the application sites will be checked to see if there is any irritation or reactions present after applications. Who is if for? You may be eligible to join this study if you are aged between 40 and 75 years, have knee pain due to osteoarthritis of the knee and are in otherwise general good health. Study details: This study will investigate two doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes a screening visit; a 1 week washout period, a 1 week baseline period; a 12 week study treatment period; and an end of study (EOS) visit at Week 12. During the washout period, participants will be asked to discontinue their anti-inflammatory agents (e.g., NSAIDs) and other analgesics prior to the Baseline Period. Only paracetemol (not more than 3 grams per day) will be allowed as rescue medication. During the Baseline Period, participants will use a 0 to 10 point numeric rating scale to capture their worst pain severity every day. Only paracetemol (not more than 3 grams per day) will be allowed as rescue medication. Participants will record rescue pain medication in a daily diary (Skin Check, Knee Pain, Rescue Medication Diary. During the treatment period four clinic visits are required for: blood sampling; review of daily diary, medications, AEs and skin irritation; measurement of blood pressure, heart rate, breathing rate and temperature ; suicide risk; and possibly, a brief physical and neurological exam, pregnancy tests (females only, if applicable) and an ECG. Participants will record rescue pain medication in a daily diary (Skin Check, Knee Pain, Rescue Medication Diary. Participants will apply all study drug to clean, dry, intact skin, thoroughly massaging it into both the right and left shoulders and/or upper arms until the area is dry.
Interventions
Participants will undergo a 1-week Washout Period to discontinue current anti-inflammatory agents (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs)) and other analgesics (except acetaminophen) followed by a 1-week Baseline Period capturing daily pain ratings using a 0 to 10 numeric rating scale (NRS). After the washout and baseline periods, participants will receive one of three treatments as indicated below:
- Treatment A: ZYN002 – CBD 250 mg every 12 hours, or
- Treatment B: ZYN002 – CBD
Participants will undergo a 1-week Washout Period to discontinue current anti-inflammatory agents (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs)) and other analgesics (except acetaminophen) followed by a 1-week Baseline Period capturing daily pain ratings using a 0 to 10 numeric rating scale (NRS). After the washout and baseline periods, participants will receive one of three treatments as indicated below: - Treatment A: ZYN002 – CBD 250 mg every 12 hours, or - Treatment B: ZYN002 – CBD 125 mg every 12 hours, or - Treatment C: placebo every 12 hours for 12 weeks. ZYN002 or placebo gel will be applied to the skin of both the right and left shoulder and/or upper arms. Participants will bring used and unused sachets to each visit for site to check treatment compliance.
Sponsors
Zynerba Pharmaceuticals Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Outcome results
None listed