Study of Diclofenac compared to Placebo for Pain Relief in Adults with Knee Osteoarthritis

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What is this study about?

This study focuses on knee osteoarthritis, a condition that causes pain and stiffness in the knee joint. The research examines how well diclofenac, a pain-relieving medication, works compared to placebo in treating knee pain. The purpose is to evaluate how a special communication approach affects the way patients report their knee pain during treatment.

The study medication comes in the form of gastro-resistant tablets. Participants will receive either diclofenac tablets or placebo tablets that look identical but contain no active medicine. The treatment period lasts for 5 weeks, during which patients take their assigned medication daily.

Throughout the study, researchers will track changes in knee pain and physical function using various measurements. They will assess how well patients can walk and how their pain levels change from the beginning to the end of the study. The research team will also monitor how patients respond to both the active medication and placebo treatment.

1 Initial assessment

Your participation begins with a screening visit where your knee pain will be evaluated using the KOOS pain questionnaire

An x-ray of your knee will be taken to confirm knee osteoarthritis severity

Your height and weight will be measured to calculate your Body Mass Index (BMI)

2 Baseline measurements

Your knee pain will be assessed again using the KOOS pain questionnaire

You will complete a 40-meter walk test to measure your walking ability

Additional pain measurements will be taken, including pressure pain threshold and pain response tests

3 Treatment period

You will receive either Diclofenac 50 mg tablets or placebo tablets

The placebo tablets contain no active medicine, only inactive ingredients (lactose and starch)

The tablets should be taken by mouth

Neither you nor the study staff will know which treatment you are receiving

4 Final assessment

At the end of the study, your knee pain will be evaluated again using the KOOS questionnaire

The 40-meter walk test will be repeated

Pain measurements will be taken again to compare with your initial results

Your daily function and knee-related symptoms will be assessed

Who Can Join the Study?

Must sign an Informed Consent Form (ICF) to participate in the study
Must be able to attend all study visits and follow all study rules about allowed medications
Must be between 40 and 85 years old when signing the consent form
Must have a Body Mass Index (BMI) less than 45 kg/m² (BMI is a measure of body fat based on height and weight)
Must have experienced knee pain on most days for at least 3 months before the screening visit
Must score at least 40 out of 100 on the KOOS pain questionnaire (a survey that measures knee pain) during both screening and baseline visits
Must have X-ray evidence of knee arthritis with a Kellgren-Lawrence grade of 2 or higher in at least one knee joint (this scale measures the severity of arthritis changes in the knee on X-rays)

Who Cannot Join the Study?

History of previous knee surgery or joint replacement in the affected knee
Presence of other types of arthritis (joint inflammation) besides osteoarthritis
Current participation in other clinical trials
Use of strong pain medications (opioids) in the past 3 months
Severe mental health conditions that could affect pain reporting
Pregnancy or planning to become pregnant during the study period
Severe knee injury or trauma within the past 6 months
Presence of other medical conditions that could affect knee pain assessment
History of substance abuse or dependency
Fibromyalgia (chronic condition causing widespread pain) or other chronic pain conditions
Unable to follow study instructions or complete questionnaires independently
Current infection or inflammation in the knee joint
Use of intra-articular injections (injections directly into the knee joint) within the past 3 months
Planned knee surgery during the study period
Severe obesity that significantly impacts knee function

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Sanos A/S	Gandrup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.06.2024

Trial locations

Investigated drugs:

Diclofenac Sodium

Diclofenac is a non-steroidal anti-inflammatory medication (NSAID) commonly used to treat pain and inflammation. It works by reducing substances in the body that cause pain and swelling. In this trial, it is being studied for its effectiveness in treating knee pain in people with osteoarthritis. This medication can be taken orally or applied directly to the skin over the painful joint.

Knee Osteoarthritis – A degenerative joint condition that affects the knee, where the protective cartilage that cushions the ends of bones gradually wears down over time. The disease typically develops slowly and causes the joint to become painful and stiff. As the condition progresses, the smooth surface of the cartilage becomes rough and thin, and the protective space between the bones decreases. The body responds by growing new bone tissue around the joint, leading to bone spurs. Joint fluid may increase, causing swelling and reducing mobility in the knee joint.

Trial ID:

2024-510757-95-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Diclofenac compared to Placebo for Pain Relief in Adults with Knee Osteoarthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?