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

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What is this study about?

This clinical trial is focused on studying the effects and safety of a new medication called ODM-111 for people experiencing long-lasting pain due to osteoarthritis of the knee. Osteoarthritis is a common joint condition that causes pain and stiffness, particularly in the knees. The study aims to evaluate how well ODM-111 works in reducing this chronic pain.

Participants in the study will receive either the new medication ODM-111, a commonly used pain reliever called Paracetamol (known as Para-Tabs 500 mg), or a placebo. The study will last for a period of six weeks, during which participants will take the medication orally in the form of tablets. The goal is to see if ODM-111 can effectively reduce knee pain compared to the other treatments.

Throughout the study, participants will be monitored to assess any changes in their pain levels and to ensure their safety. The primary focus is on the change in pain from the beginning of the study to the end of the six-week period, using a specific pain measurement scale. This research is important for finding new ways to help people manage chronic knee pain caused by osteoarthritis.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria, such as age, body mass index (BMI), and the presence of chronic pain due to osteoarthritis in the knee.

You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and potential risks.

2 baseline assessments

Baseline assessments will be conducted to evaluate your current condition. This includes measuring your pain levels using a scale called the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a numerical rating scale (NRS).

These assessments help establish a starting point for your pain levels before beginning the treatment.

3 treatment phase

During the treatment phase, you will receive either the study medication ODM-111 or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

The medication will be administered orally in the form of tablets. The specific dosage and frequency will be provided by the study team.

This phase will last for a specified duration, during which you will continue to take the medication as instructed.

4 follow-up visits

You will attend regular follow-up visits to monitor your progress and any changes in your condition. These visits are important to ensure your safety and to assess the effectiveness of the treatment.

During these visits, you will undergo similar assessments as the baseline to track changes in your pain levels and overall health.

5 end of study visit

At the end of the study, you will have a final visit to conclude your participation. This visit will include a comprehensive assessment of your condition and any effects of the treatment.

You will be provided with information about the next steps and any follow-up care if necessary.

Who Can Join the Study?

Must provide a signed informed consent to participate in the trial.
Must be a male or female who is 40 years of age or older at the time of the screening visit.
Must have a Body Mass Index (BMI) between 18 and 40 kg/m² at the screening visit. BMI is a measure of body fat based on height and weight.
Must have a diagnosis of osteoarthritis (OA) in the knee according to specific medical criteria and a certain grade of severity in the knee joint at the screening visit.
The knee osteoarthritis must be the main source of pain, and pain in the most affected knee must have been present for more than 6 months at the screening visit.
Must have a certain level of pain in the affected knee as measured by specific pain scales at both the screening and baseline visits.
Must be classified as ACR Functional class I-III, which refers to the level of physical function.
If female participants have male partners who can father children, or if male participants have female partners who can become pregnant, they must use a highly effective form of birth control if sexually active and not permanently sterilized. This applies to females from 4 weeks before the first study treatment and to males from Day 1 until 3 months after the end of the study. Women who have not had a menstrual cycle for 1 year are considered not able to have children and can be included. Male participants cannot donate sperm until 3 months after the end of the study.

Who Cannot Join the Study?

Patients who have any other significant health problems that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a knee surgery in the last 6 months.
Patients who are allergic to the study medication or its ingredients.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or instructions.
Patients who have a condition that affects their ability to give informed consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
Praxis Reinfeld Mitte	Reinfeld	Germany
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Klinische Forschung Karlsruhe GmbH	Karlsruhe	Germany
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Sanos A/S	Gandrup	Denmark
Pratia Brno s.r.o.	Brno-Stred	Czechia
Reumed Sp. z o.o.	Lublin	Poland
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
CCR Ostrava s.r.o.	Moravska Ostrava A Privoz	Czechia
Hospital Hm Rosaleda Hm La Esperanza	Santiago De Compostela	Spain
Institut Ferran De Reumatologia S.L.	Barcelona	Spain
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.	Olsztyn	Poland
Neurohk s.r.o.	Chocen	Czechia
Pratia Pardubice a.s.	Pardubice	Czechia
Pratia S.A.	Skorzewo	Poland
Siteworks GmbH	Hanover	Germany
Klinische Forschung Berlin GbR	Berlin	Germany
HELIOS Kliniken Schwerin GmbH	Schwerin	Germany
Reumatologerne Beier & Morillon	Odense	Denmark
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.	Elblag	Poland
Meifwvuqs Ioxrpnutje Cuoxptfz Scgscmtv Smv z oxrp	Warsaw	Poland
Foavpxxjfi Gaya	Offenbach Am Main	Germany
Mlpygqw cnqjsx Jlfomjwg snjxis	Ricany	Czechia
Pqojb Dfx mbuj Gyrhncd Nnnqi Myd Gwjp	Bad Doberan	Germany
Hoiigw Hcxhhqhg	Herlev	Denmark
Fnnkdlcog Pjbq Lu Iejvlmqgusnnq Baegcngxf Dvr Hipjejrk Ubawtqrunjlim Lz Pvg	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.12.2024
Denmark	Not recruiting	01.12.2024
Germany	Not recruiting	01.12.2024
Poland	Not recruiting	01.12.2024
Spain	Not recruiting	01.12.2024

Trial locations

Investigated drugs:

Paracetamol

ODM-111 is a medication being studied for its ability to help manage chronic pain in people with knee osteoarthritis. Osteoarthritis is a condition that causes the joints to become painful and stiff. This medication is being tested to see if it can reduce the pain and improve the quality of life for those suffering from this condition. The trial aims to find out how well ODM-111 works and how well people can tolerate it, meaning how it affects them and if there are any side effects.

Osteoarthritis of the Knee – Osteoarthritis of the knee is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. As the cartilage wears away, bones begin to rub against each other, causing pain, swelling, and reduced motion in the joint. Over time, the joint may become stiff and lose its normal shape. Small bone growths, called osteophytes or bone spurs, may form around the joint. The condition typically progresses slowly, with symptoms worsening over time. It is most common in older adults and can be influenced by factors such as age, weight, and previous joint injuries.

Trial ID:

2024-513553-79-00

Protocol code:

3133003

Trial Phase:

Therapeutic exploratory (Phase II)

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