Study of ZYN002 (transdermal gel) in Patients with Knee Pain due to Osteoarthritis

Phase 2

Completed

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12616001104448
• Lead Sponsor: Zynerba Pharmaceuticals Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of ZYN002 administered as a transdermal gel for 12 weeks as treatment for knee pain due to osteoarthritis (OA) of the knee. <br>Assessed by: change in weekly mean of the 24-hour average worst pain score, change in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score, rescue pain medication usage, [Assessed at every study visit from Screening visit to End of study visit (baseline, Day 1, Weeks 4, 8 and 12).]

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of ZYN002 in osteoarthritis (OA) patients. <br>Assessed by: monitoring side effects, physical examinations, electrocardiogram and neurological exams.<br>Studies to date have demonstrated that ZYN002 is generally well tolerated with most common side effect is site application dryness. There have also been some reports of headache. Most side effects have been mild in nature and similar between placebo patients and those receiving ZYN002.[Safety will be assessed at every study visit from Screening visit to End of study visit (baseline, Day 1, Weeks 4, 8 and 12).];To evaluate the tolerability of ZYN002 in osteoarthritis (OA) patients. <br>Assessed by: skin assessment, blood and urine tests, measuring vital signs, completion of Columbia Suicidality Severity Rating Scale (C-SSRS) and presence of effusion in the knee.[Tolerability will be assessed at every study visit from Screening visit to End of study visit (baseline, Day 1, Weeks 4, 8 and 12).]