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CompletedPhase 2ACTRN12623000273684

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

Sponsor

Andros Pharmaceuticals Pty Ltd

Enrollment

60 participants

Start Date

Feb 9, 2024

Study Type

Interventional

Conditions

Pain associated with osteoarthritis of the knee

Summary

This is a phase 2, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of twice daily APC201, for 4 weeks in adults with osteoarthritic pain of the knee. This will be done by analysing pain score and skin check, knee pain and rescue medication diary, and side effects. Safety will be monitored during treatment visits using standard measures, including physical exams, vital signs, 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. The primary purpose of phase 2 study is to evaluate the clinical efficacy and safety of APC201 in reducing pain in patients with osteoarthritis of the knee compared with those on placebo.

Eligibility

Sex: Both males and femalesMin Age: 35 YearssMax Age: 85 Yearss

Inclusion Criteria13

  • Male or female Adult, 35 to 85 years of age, inclusive at the time of screening.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Except for osteoarthritis, in reasonably good health as assessed by the Investigator.
  • Subject is able to provide written informed consent.
  • Subject agrees to maintain the usual level of activity throughout the course of the study.
  • Subject must agree to not showering, swimming or wetting the treated knee(s) within 2 hours of application.
  • Subject must agree to avoid exposing the treated knee(s) to natural or artificial sunlight.
  • The subject has a body mass index (BMI) is greater than or equal to 18.5 and less than 40.

Exclusion Criteria27

  • 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.
  • Known presence of gastrointestinal ulcer or any gastrointestinal bleeding within 6 months prior to Day 1.
  • 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.
  • 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.
  • Major surgery or arthroscopy of the target knee within one year prior to Day 1.
  • History of knee replacement.
  • Planned surgery of the target knee within 3 months of the screening visit.
  • 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.
  • Medical history of coronary artery bypass graft surgery.
  • 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.
  • Secondary osteoarthritis of the target knee, previous procedures or trauma affecting joint of the target knee.
  • Reported incidence of any of the following diseases: known osteoarthritis of the hip(s) if pain in hip(s) exceeds that of the target knee, presence of significant back pain, or at least one migraine attack within the past 12 months before Day 1, as reported by the subject.
  • Generalized skin irritation, previous skin reactions upon use of topical NSAIDs, current skin irritation or redness at the planned site of application, or significant skin disease including psoriasis, as judged by the investigator.
  • Prior stable therapy (more than 3 days a week for the month prior to Day 1) with an opioid analgesic or use of an opioid analgesic with 7 days prior to Day 1.
  • Use of duloxetine, pregabalin, or gabapentin within 30 days prior to Day 1.
  • History of alcohol or drug abuse within the past year prior to Day 1.
  • Donation or significant loss of blood (480 mL or more) within 60 days prior to Day1.
  • Administration of other investigational drugs within 30 days prior to Day 1.
  • Smoked or used nicotine-containing products within 6 months prior to Day 1.
  • Subject is not likely to complete the study for any reason as judged by the investigator.
  • Abnormal hepatic, renal or hematologic findings at screening:
  • The value of Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2.5 times upper limit of normal;
  • The value of Total bilirubin is greater than or equal to 1.5 times upper limit of normal;
  • The value of Serum creatinine is greater than or equal to 1.5 times upper limit of normal;
  • The value of Hemoglobin is less than or equal to lower limit of normal.
  • Has used cannabis or any CBD or THC-containing product within 30 days of the screening visit and during the study.
  • Subject plans to use any OTC cosmetic tanning lotions to the target knee while on study.

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Interventions

Apply APC201 topically twice daily on affected knee(s) for 4 weeks. The intended dose of APC201 per administration is 3 actuations (0.75 mL x 3=2.25mL), equivalent to 94 mg of diclofenac sodium per k

Apply APC201 topically twice daily on affected knee(s) for 4 weeks. The intended dose of APC201 per administration is 3 actuations (0.75 mL x 3=2.25mL), equivalent to 94 mg of diclofenac sodium per knee for each administration. After screening, participants are randomly assigned to three treatment groups; Group 1 (Once a day arm of APC201) applied APC201 in the morning (AM) and Placebo at night (PM). Group 2 (Twice a day arm of APC201) applied APC201 in the AM and PM and Group 3 (Placebo arm) applied placebo in the AM and PM. A participant’s adherence to the assigned treatment plan will be assessed by reviewing entries on his/her diary card at each return visit.

Locations(1)

Taiwan, Province Of China

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ACTRN12623000273684