Study on the Effects of DFV890 for Pain Relief in Patients with Knee Osteoarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for knee osteoarthritis, a common condition that causes pain and stiffness in the knee joint. The treatment being tested is called DFV890, which is taken as a film-coated tablet. The study will compare the effects of DFV890 to a placebo, which looks like the treatment but does not contain the active ingredient.

The purpose of the study is to determine how effective DFV890 is in relieving knee pain in people with knee osteoarthritis. Participants in the study will take either DFV890 or a placebo for a period of 12 weeks. During this time, researchers will monitor changes in knee pain and other symptoms using a specific scoring system. The study will also look at the safety and tolerability of DFV890, which means checking for any side effects or adverse reactions.

Throughout the study, participants will have regular check-ups to assess their knee condition and overall health. This will include various tests and measurements, such as blood tests and imaging techniques like MRI (Magnetic Resonance Imaging), to evaluate the level of inflammation in the knee. The study aims to provide valuable information on whether DFV890 can be a beneficial treatment option for those suffering from knee osteoarthritis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, weight, body mass index (BMI), and specific health markers such as high sensitivity C-reactive protein levels and knee pain scores.

A detailed medical history and physical examination are performed to ensure the presence of knee osteoarthritis and to assess the severity of the condition.

2 randomization and baseline measurements

Participants are randomly assigned to one of two groups: one receiving the active medication DFV890 and the other receiving a placebo.

Baseline measurements are taken, including the Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale and other health indicators.

3 medication administration

Participants in the active group receive DFV890 in the form of film-coated tablets for oral use. The dosage is determined by the study protocol.

Participants in the placebo group receive tablets that look identical to the active medication but contain no active ingredients.

4 follow-up assessments

Regular follow-up assessments are conducted at weeks 2, 4, 8, and 12 to monitor changes in knee pain and other health parameters.

These assessments include measuring changes in the KOOS pain sub-scale, synovitis activity levels, and other health markers such as C-reactive protein levels and neutrophil counts.

5 final evaluation

At week 12, a final evaluation is conducted to assess the overall efficacy and safety of the treatment.

This includes a comprehensive review of all collected data, including any adverse events, changes in pain levels, and other health indicators.

Who Can Join the Study?

Participants must be men or women who are between 50 and 80 years old on the day they sign the consent form.
Participants must weigh at least 50 kg and have a body mass index (BMI) between 18 and 35. BMI is a measure that uses your weight and height to estimate if you have a healthy body weight.
Participants must have a high sensitivity C-reactive protein (hsCRP) level of 1.8 mg/L or higher. hsCRP is a blood test that measures inflammation in the body.
Participants must have knee osteoarthritis with pain levels between 5 and 9 on a scale from 0 to 10, where 10 is the worst pain, for most days in the last 3 months.
Participants must have a score of 60 or less on the KOOS pain sub-scale for the affected knee. This is a questionnaire that measures knee pain.
Participants must have knee osteoarthritis that is classified as K&L grade 2 or 3. This is a way to describe the severity of the condition using X-rays.
Participants must have active inflammation in the knee joint lining, shown by a contrast-enhanced MRI (CE-MRI) scan. This is a special imaging test that helps detect inflammation in the knee.

Who Cannot Join the Study?

Patients who have had a knee replacement surgery cannot participate.
Individuals with other types of arthritis, like rheumatoid arthritis, are not eligible.
People who have had a recent injury to the knee, such as a fracture or ligament tear, are excluded.
Participants who are currently taking certain medications that might interfere with the study are not allowed.
Individuals with severe heart, liver, or kidney problems cannot join the study.
Pregnant or breastfeeding women are not eligible to participate.
Patients with a history of drug or alcohol abuse are excluded.
Anyone who has participated in another clinical trial within the last 30 days is not eligible.
Individuals with a known allergy to the study medication or similar drugs cannot participate.
People with uncontrolled diabetes or high blood pressure are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania

Other Sites

Site Name	City	Country
SYNEXUS Magyarorszag Kft.	Budapest	Hungary
Charite Research Organisation GmbH	Berlin	Germany
Hospital Del Mar	Barcelona	Spain
Ambenet GmbH Das Ambulante Behandlungsnetz	Leipzig	Germany
Qualiclinic Kft.	Budapest	Hungary
Centrul Medical Monza S.R.L.	Bucharest	Romania
Revita Kft.	Budapest	Hungary
Medical Plus s.r.o.	Uherske Hradiste	Czechia
BIOMEDRO Biomedizinische Forschung und Entwicklung GmbH	Bad Doberan	Germany
Clinical Research Hamburg GmbH	Hamburg	Germany
Hospital Hm Rosaleda Hm La Esperanza	Santiago De Compostela	Spain
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
Nemocnice AGEL Novy Jicin a.s.	Novy Jicin	Czechia
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Klinische Forschung Berlin GbR	Berlin	Germany
Pratia Brno s.r.o.	Brno-Stred	Czechia
Vital Medical Center	Veszprem	Hungary
Kjrpxscdr Fendduzhj Djjmkir Gbvb	Dresden	Germany
Pcrqke fqoa Kghpagtyn Szwqhga Di mzn Asjvf uhg Dx mnf Gnchf Drwknv	Hamburg	Germany
Ldqykpu Bss	Kecskemet	Hungary
Ptow Twexj Hsfwmxuq Uooispzmnftm	Sabadell	Spain
Hjnzyjxs Ummulwbytaveg dd A Cqrawb	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	05.07.2021
Germany	Not recruiting	05.07.2021
Hungary	Not recruiting	05.07.2021
Romania	Not recruiting	05.07.2021
Spain	Not recruiting	05.07.2021

Trial locations

Investigated drugs:

DFV890 is a medication being studied for its potential to relieve pain in patients with knee osteoarthritis. The trial aims to assess how effective DFV890 is in reducing pain compared to a placebo. Participants in the study receive DFV890 to see if it can improve their knee pain over a 12-week period, as measured by a specific pain scoring system.

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. This condition leads to pain, stiffness, and swelling, which can worsen over time. As the cartilage wears away, bones may rub against each other, causing increased discomfort and reduced mobility. The progression of knee osteoarthritis can vary, with some individuals experiencing gradual worsening of symptoms. Factors such as age, weight, and previous joint injuries can influence the development and progression of the disease. Regular physical activity and maintaining a healthy weight can help manage symptoms and slow progression.

Trial ID:

2023-507559-30-00

Protocol code:

CDFV890B12201

NCT ID:

NCT04886258

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of DFV890 for Pain Relief in Patients with Knee Osteoarthritis

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