A Phase II Study to Investigate the Safety and efficacy of APC201 for the Treatment of Pain Associated with Osteoarthritis of the Knee

Andros Pharmaceuticals Pty Ltd0 sites60 target enrollmentMarch 14, 2023

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Andros Pharmaceuticals Pty Ltd
Enrollment: 60
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 14, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Andros Pharmaceuticals Pty Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Male or female Adult, 35 to 85 years of age, inclusive at the time of screening.
•2\. If female of childbearing potential, subject must be not pregnant as assessed by a pregnancy test at screening and agree to use an acceptable method of contraception (progestogen\-only hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) from enrolment up to 30 days after the study end. Female subject being postmenopausal for at least 1 year or surgically sterile is considered to be of no childbearing potential.
•3\. The subject is diagnosed with osteoarthritis of the knee for at least 3 months, according to the American College of Rheumatology (ACR) clinical and X\-ray criteria.
•4\. X\-ray of target knee(s) showing osteoarthritis of Kellgren\-Lawrence grade 2 or above within 90 days of screening. If greater than 90 days an X\-Ray will be required at time of screening period.
•5\. WOMAC pain sub\-score (5 questions) higher than or equal to 8 and lower than or equal to 18 in the target knee, at the time of screening and at Baseline.
•6\. Knee pain in the target knee for 14 days of the preceding month (knee pain due to osteoarthritis and not due to another condition such as bursitis, tendinitis, etc.) at screening based on subject report.
•7\. On stable pain therapy (i.e., at least 3 days per week for the previous month) with an oral NSAID prescribed by physician and/or over\-the\-counter for 30 days prior to the start of screening.
•8\. Except for osteoarthritis, in reasonably good health as assessed by the Investigator.
•9\. Subject is able to provide written informed consent.
•10\. Subject agrees to maintain the usual level of activity throughout the course of the study.

Exclusion Criteria

•1\. Known or suspected hypersensitivity to NSAIDs (non\-steroidal anti\-inflammatory drugs), any of the components in either of the investigation products, or any physical impediment to apply IP on the target knee.
•2\. Known presence of gastrointestinal ulcer or any gastrointestinal bleeding within 6 months prior to Day 1\.
•3\. Injection of corticosteroids or hyaluronic acid in the target knee within 6 months of Day 1 or into any other joint within 30 days of Day 1\.
•4\. High dose oral/injected corticosteroid (more than 30 mg prednisone equivalent a day) treatment of more than 14 days during the past 6 months prior to Day 1\.
•5\. Major surgery or arthroscopy of the target knee within one year prior to Day 1\.
•6\. History of knee replacement.
•7\. Planned surgery of the target knee within 3 months of the screening visit.
•8\. Presence of an additional non\-osteoarthritic disease affecting either knee, such as reactive arthritis, crystalline arthritis, ankylosing spondylitis, fibromyalgia, rheumatoid arthritis, psoriasis, gout or pseudo\-gout, if there is reason to believe that the disease(s) may significantly interfere with the interpretation of the clinical response to the study drug.
•9\. Medical history of coronary artery bypass graft surgery.
•10\. Current cancer or treatment for cancer within the past five years, with the exception of non\-melanoma skin cancer, unless affecting the target knee area.