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Paeonol

This article discusses a clinical trial investigating the use of a drug combination called APPA, which contains paeonol and apocynin, for treating knee osteoarthritis. The study aims to assess the effectiveness, safety, and tolerability of APPA in reducing pain and improving symptoms, physical functioning, and quality of life in adults with knee osteoarthritis. This placebo-controlled, double-blinded, randomized trial will help determine the optimal dosage for potential future treatments.

Table of Contents

What is PAEONOL?

PAEONOL is an investigational drug being studied for the treatment of knee osteoarthritis. It is part of a combination medication called APPA, which consists of two active substances: paeonol and apocynin[1]. This medication is being developed as a potential new therapy for people suffering from knee osteoarthritis pain.

Medical Condition: Knee Osteoarthritis

Knee osteoarthritis is a common form of arthritis that affects the knee joint. It occurs when the protective cartilage that cushions the ends of the bones in the knee wears down over time. This condition can cause pain, stiffness, and reduced mobility in the affected knee[1].

Clinical Trial Information

A clinical trial is currently underway to evaluate the effectiveness and safety of APPA (the combination of paeonol and apocynin) for treating knee osteoarthritis. This trial is known as a phase II study, which means it aims to gather more information about the drug’s effectiveness and safety in a larger group of patients[1].

The study is described as a “placebo-controlled, double-blinded, randomized, dose-finding trial.” Let’s break down what this means:

  • Placebo-controlled: Some participants will receive a placebo (a substance with no active ingredients) instead of the actual drug. This helps researchers determine if the drug’s effects are genuinely due to the medication itself.
  • Double-blinded: Neither the participants nor the researchers directly involved in the study know who is receiving the actual drug and who is receiving the placebo. This helps prevent bias in the study results.
  • Randomized: Participants are randomly assigned to either the treatment group (receiving APPA) or the placebo group.
  • Dose-finding: The study aims to determine the most effective and safe dose of the medication[1].

How PAEONOL Works

While the exact mechanism of action is not fully described in the provided information, PAEONOL is being studied as part of the APPA combination for its potential to relieve pain and improve symptoms associated with knee osteoarthritis. The combination of paeonol and apocynin may have anti-inflammatory and pain-relieving properties that could benefit patients with this condition[1].

Eligibility Criteria for the Study

To participate in this clinical trial, patients must meet certain criteria. Some key inclusion criteria include:

  • Age between 40 and 85 years
  • Diagnosed with femorotibial osteoarthritis of the knee
  • Specific level of knee pain as measured by a standardized scale (WOMAC pain sub-score)
  • Previous failure or intolerance to at least one other osteoarthritis therapy[1]

There are also several exclusion criteria, such as certain medical conditions, recent surgeries, or use of specific medications that would prevent participation in the study[1].

Study Objectives

The main goal of this clinical trial is to evaluate how APPA affects pain in the target knee. Additionally, the study aims to assess:

  • Safety and tolerability of APPA
  • Changes in overall osteoarthritis symptoms
  • Improvements in physical functioning
  • Changes in quality of life for patients taking the medication[1]

Potential Benefits of PAEONOL

If proven effective, PAEONOL (as part of the APPA combination) could offer several potential benefits for patients with knee osteoarthritis:

  • Reduced knee pain
  • Improved physical function and mobility
  • Better quality of life
  • A new treatment option for those who haven’t responded well to other therapies[1]

Safety Considerations

As with any investigational drug, safety is a crucial aspect of the study. The researchers will be closely monitoring participants for any side effects or adverse reactions. Some safety measures in the study include:

  • Regular monitoring of vital signs, laboratory tests, and electrocardiogram (ECG) parameters
  • Tracking the nature, incidence, and severity of any adverse events
  • Excluding participants with certain medical conditions or those taking medications that could interact with the study drug[1]

It’s important to note that as an investigational drug, the full safety profile of PAEONOL is not yet known, and more research is needed to fully understand its potential risks and benefits.

Aspect Details
Study Type Phase II, placebo-controlled, double-blinded, randomized, dose-finding trial
Drug APPA (combination of apocynin and paeonol)
Condition Knee osteoarthritis
Primary Objective Evaluate change in pain of the target knee
Secondary Objectives Evaluate safety, tolerability, changes in OA symptoms, physical functioning, and quality of life
Key Inclusion Criteria Age 40-85, femorotibial osteoarthritis, specific pain and radiological criteria
Key Exclusion Criteria Hypersensitivity to APPA, current malignancy, BMI ≥ 40 kg/m2, certain medication use
Primary Endpoint Change from baseline in WOMAC pain sub-score at week 12
Key Secondary Endpoints Changes in WOMAC total score, ICOAP scores, quality of life, adverse events
Maximum Daily Dose 2400 mg
Treatment Duration 84 days (12 weeks)

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the change in pain of the target knee using a combination of apocynin and paeonol (APPA) for treating knee osteoarthritis.
  • Who can participate in this study? Participants must be between 40 and 85 years old, have femorotibial osteoarthritis of the knee, and meet specific criteria for pain levels and radiological OA grade. They must also have failed to respond to or not tolerated at least one previous OA therapy.
  • What are some of the exclusion criteria for this trial? Some exclusion criteria include known hypersensitivity to APPA, current malignancy, prior septic arthritis of the target knee, body mass index ≥ 40 kg/m2, and use of certain medications like strong opioids or serotonin–norepinephrine reuptake inhibitors within specified timeframes.
  • How long does the trial last? The trial lasts for 12 weeks, with the primary endpoint being evaluated at week 12.
  • What are the main outcomes being measured in this study? The main outcomes include changes in WOMAC pain sub-score, WOMAC total score, constant and intermittent OA pain, quality of life, and the nature and severity of any adverse events. The study will also assess the use of rescue medication and changes in various laboratory safety parameters.

Ongoing Clinical Trials on Paeonol

  • Study on Apocynin and Paeonol for Knee Osteoarthritis Pain Relief in Adults

    Not recruiting

    1 1
    Investigated drugs:
    Denmark

Glossary

  • Osteoarthritis (OA): A type of joint disease that results from breakdown of joint cartilage and underlying bone, causing pain, stiffness, and reduced movement in the affected joint.
  • APPA: A combination drug containing apocynin and paeonol, being studied for the treatment of knee osteoarthritis.
  • Paeonol: One of the active substances in APPA, derived from the bark of the root of the peony tree, known for its anti-inflammatory properties.
  • Apocynin: The other active substance in APPA, also known for its anti-inflammatory effects.
  • WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index, a widely used set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee and hip.
  • Kellgren-Lawrence method: A system used to classify the severity of knee osteoarthritis using five grades.
  • PainDETECT: A screening tool used to identify neuropathic pain components in patients.
  • ICOAP: Intermittent and Constant Osteoarthritis Pain scale, used to measure pain in osteoarthritis.
  • OMERACT-OARSI: A set of response criteria for osteoarthritis clinical trials, developed by the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International.
  • Patient Global Assessment (PGA): A measure used in clinical trials where patients rate their overall well-being or disease activity.
  • EQ5D: A standardized instrument for measuring generic health status and quality of life.

References

  1. http://clinicaltrials.eu/trial/study-on-apocynin-and-paeonol-for-knee-osteoarthritis-pain-relief-in-adults/