Evaluation of ODM-111 and Paracetamol in the Management of Chronic Pain Associated with Knee Osteoarthritis: A Randomized Controlled Trial

The primary objective of this study is to evaluate the **efficacy** of ODM-111 in the treatment of chronic pain due to knee osteoarthritis. This is clinically relevant as chronic pain significantly impacts the quality of life and functional ability of patients with osteoarthritis, and effective management is crucial for improving patient outcomes.

Secondary objectives include assessing the **tolerability** of ODM-111. Understanding the tolerability profile is essential to ensure that the treatment is not only effective but also safe and well-tolerated by patients, which is critical for long-term management of chronic conditions.

The clinical trial investigating the efficacy of ODM-111 in the treatment of **chronic pain due to osteoarthritis of the knee** includes a total of 60 participants. The study population comprises both male and female subjects aged 40 years and older, with a **Body Mass Index (BMI)** ranging from 18 to 40 kg/m². Participants were selected based on a confirmed diagnosis of osteoarthritis (OA) according to the American College of Rheumatology criteria, with a Kellgren-Lawrence grade of 2-4 in the index knee joint. The trial includes individuals for whom OA of the knee is the primary painful condition, with pain persisting for more than six months. The study population is characterized by a range of functional classes (I-III) as per the ACR classification. Participants are required to adhere to specific contraceptive measures if they are of reproductive potential, ensuring compliance with the study's safety protocols. The trial does not exclude vulnerable populations, indicating a broad inclusion of individuals who meet the specified criteria.

The clinical trial is designed to evaluate the **efficacy** and tolerability of ODM-111 in the treatment of chronic pain due to osteoarthritis of the knee. This is a Phase 4, randomized, double-blind, placebo-controlled trial. The trial will involve the administration of ODM-111, a chemical compound, and a placebo, both in tablet form, to participants. The trial is expected to commence on December 1, 2024, and conclude by October 30, 2026, with a maximum treatment period of six weeks for each participant.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age, body mass index, and the presence of osteoarthritis according to the American College of Rheumatology criteria. The primary painful condition must be osteoarthritis of the knee, with pain persisting for more than six months. The primary endpoint is the change from baseline to week 6 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale.

Following the screening visit, eligible participants will be randomized to receive either ODM-111 or a placebo. The trial will include follow-up visits to monitor the participants' response to the treatment and any adverse effects. The end-of-study visit will mark the conclusion of the participant's involvement, which is expected to last approximately six weeks. Conditions that may lead to early termination from the study include non-compliance with the study protocol or the occurrence of significant adverse events.

The clinical trial involves the administration of **ODM-111**, an investigational medication, to evaluate its efficacy in treating chronic pain due to knee osteoarthritis. **ODM-111** is provided in the form of tablets and is administered orally. The maximum treatment period for **ODM-111** is six months. The specific dosage and frequency of administration are not detailed in the available data. The active substance in **ODM-111** is chemically derived and is identified by the sponsor product code **ODM-111**. The trial also includes a placebo group, where participants receive **ODM-111 Placebo**. The placebo is designed to mimic the appearance and administration route of the active medication, ensuring blinding in the study.

In addition to the investigational product, the trial utilizes **Para-Tabs 500 mg tabletti** as a comparator treatment. This medication contains **paracetamol** as the active ingredient and is administered in tablet form. The route of administration is oral, with a maximum daily dose of 3 grams and a total maximum dose of 126 grams over the treatment period. The treatment period for **Para-Tabs 500 mg tabletti** is also set at six months. **Para-Tabs 500 mg tabletti** is manufactured by Orion Corporation and is chemically derived. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the protocol.

The efficacy of ODM-111 in the treatment of chronic pain due to knee **osteoarthritis** will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The primary efficacy endpoint is defined as the change from baseline to week 6 in the WOMAC pain subscale score. This validated scale is specifically designed to evaluate pain levels in patients with osteoarthritis, providing a reliable measure of symptom improvement.