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Odm-111

ODM-111 is a promising drug currently being studied in clinical trials for its potential in managing chronic pain conditions. These trials are focusing on two specific areas: osteoarthritis of the knee and diabetic peripheral neuropathy. The studies aim to evaluate the efficacy and safety of ODM-111 in providing relief to patients suffering from these debilitating conditions. By participating in these trials, researchers hope to gain valuable insights into new treatment options for chronic pain management.

Table of Contents

What is ODM-111?

ODM-111 is a new medication being developed by Orion Corporation for the treatment of chronic pain[1][2]. It is currently undergoing clinical trials to evaluate its effectiveness and safety in treating specific types of chronic pain conditions.

What Conditions Does ODM-111 Treat?

ODM-111 is being studied for the treatment of two main chronic pain conditions:

  • Chronic pain due to osteoarthritis of the knee: This is a type of joint pain caused by wear and tear of the knee joint, which can lead to long-lasting discomfort and reduced mobility[1].
  • Chronic pain due to diabetic peripheral neuropathy (DPN): This is a type of nerve pain that affects people with diabetes, primarily in their legs and feet[2].

How Does ODM-111 Work?

While the exact mechanism of action for ODM-111 is not provided in the available information, it is being developed as a potential treatment for chronic pain. The medication is being tested to see if it can effectively reduce pain levels in patients with osteoarthritis of the knee and diabetic peripheral neuropathy.

Clinical Trials for ODM-111

ODM-111 is currently being evaluated in two separate clinical trials:

  1. CHRONOS Study: This trial is focusing on patients with chronic pain due to osteoarthritis of the knee. The main goal is to assess how well ODM-111 works in reducing knee pain over a 6-week period[1].
  2. Diabetic Peripheral Neuropathy Study: This trial is evaluating the effectiveness of ODM-111 in treating chronic pain caused by diabetic peripheral neuropathy. The primary aim is to measure the change in pain intensity over a 6-week period[2].

Both trials are using standardized pain scales to measure the effectiveness of ODM-111 compared to a placebo (a dummy treatment with no active ingredients).

Who is Eligible for ODM-111 Treatment?

The eligibility criteria for the ODM-111 clinical trials include:

  • For the osteoarthritis study:
    • Adults aged 40 years or older
    • Diagnosed with osteoarthritis of the knee
    • Experiencing chronic knee pain for more than 6 months
    • Meeting specific pain intensity criteria
  • For the diabetic peripheral neuropathy study:
    • Adults aged 18 to 80 years
    • Diagnosed with Type 1 or Type 2 diabetes for at least 6 months
    • Experiencing painful diabetic peripheral neuropathy for at least 6 months
    • Meeting specific pain intensity criteria

It’s important to note that these criteria are for the clinical trials and may not reflect the final eligibility criteria if ODM-111 becomes an approved treatment[1][2].

How is ODM-111 Administered?

ODM-111 is being tested in tablet form and is taken orally (by mouth)[1][2]. The exact dosage and frequency of administration are not provided in the available information and may vary depending on the specific study and condition being treated.

Potential Side Effects and Precautions

As ODM-111 is still in the clinical trial phase, comprehensive information about its side effects is not yet available. However, the trials exclude individuals with known hypersensitivity to the active substance or any of the excipients in ODM-111[1][2].

Additionally, the trials have specific exclusion criteria to ensure patient safety, such as:

  • Pregnancy or breastfeeding
  • Certain medical conditions that might interfere with the study results or pose additional risks
  • Use of certain medications that might interact with ODM-111

It’s important to remember that ODM-111 is still an investigational drug, and its full safety profile will be determined through these clinical trials and potential future studies.

Aspect Osteoarthritis Trial Diabetic Peripheral Neuropathy Trial
Main Objective Evaluate efficacy of ODM-111 in chronic knee OA pain Evaluate efficacy of ODM-111 in chronic DPN pain
Age Range ≥ 40 years 18 to 80 years
BMI Requirement 18-40 kg/m² 18-45 kg/m²
Primary Endpoint Change in WOMAC pain subscale at 6 weeks Change in daily pain intensity on NRS at 6 weeks
Key Inclusion Criteria OA diagnosis, pain for >6 months Diabetes diagnosis, DPN pain for ≥6 months
Key Exclusion Criteria Joint replacement, recent surgery HbA1c >10%, non-diabetic neuropathy
Allowed Concurrent Medication Paracetamol as rescue (up to 3g daily) Gabapentin, pregabalin, or duloxetine (stable dose)

FAQ

  • What is ODM-111? ODM-111 is an investigational drug being studied for its potential in treating chronic pain conditions, specifically in osteoarthritis of the knee and diabetic peripheral neuropathy.
  • What types of chronic pain is ODM-111 being tested for? ODM-111 is currently being tested in clinical trials for chronic pain due to osteoarthritis of the knee and chronic pain caused by diabetic peripheral neuropathy.
  • Who can participate in these clinical trials? Eligibility varies between trials, but generally includes adults aged 18-80 with specific diagnoses of osteoarthritis or diabetic peripheral neuropathy, meeting certain pain level criteria, and without specific exclusionary conditions.
  • How long do the clinical trials for ODM-111 last? The primary endpoint for both trials is measured at 6 weeks, suggesting that the main treatment period lasts for at least 6 weeks.
  • What is the main goal of these clinical trials? The main objective of these trials is to evaluate the efficacy and tolerability of ODM-111 in treating chronic pain associated with osteoarthritis of the knee and diabetic peripheral neuropathy.

Ongoing Clinical Trials on Odm-111

  • Study on the Effects and Safety of ODM-111 and Paracetamol for Chronic Knee Pain in Osteoarthritis Patients

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Germany Poland Spain

  • Study on the Effectiveness of ODM-111 and Paracetamol for Chronic Pain in Patients with Diabetic Peripheral Neuropathy

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Germany Hungary Poland

Glossary

  • Osteoarthritis (OA): A type of joint disease that results from breakdown of joint cartilage and underlying bone, often affecting the knees.
  • Diabetic Peripheral Neuropathy (DPN): Nerve damage caused by diabetes, typically affecting the feet and legs, leading to pain, numbness, or tingling sensations.
  • 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.
  • Numerical Rating Scale (NRS): A pain scale from 0 to 10 used to measure pain intensity, where 0 represents no pain and 10 represents the worst pain imaginable.
  • HbA1c: A blood test that measures average blood sugar levels over the past 2-3 months, used to diagnose and monitor diabetes.
  • BMI: Body Mass Index, a measure that uses your height and weight to work out if your weight is healthy.
  • Placebo: A substance or treatment with no active therapeutic effect, used in clinical trials as a control to compare with the drug being tested.
  • Efficacy: The ability of a drug or treatment to produce a desired effect.
  • Tolerability: The degree to which side effects of a drug can be tolerated by a patient.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-and-safety-of-odm-111-and-paracetamol-for-chronic-knee-pain-in-osteoarthritis-patients/
  2. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-odm-111-and-paracetamol-for-chronic-pain-in-patients-with-diabetic-peripheral-neuropathy/