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Study on the Effectiveness of Diclofenac Gel AMZ001 for Treating Knee Osteoarthritis Pain in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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 a gel called AMZ001, which contains the active ingredient diclofenac sodium. This gel is applied to the skin over the knee to help reduce pain and improve movement. The study will also use a placebo to compare the effects of the gel with no active treatment.

The purpose of the study is to evaluate how effective and safe the diclofenac gel AMZ001 is in reducing knee pain and symptoms associated with osteoarthritis. Participants in the study will apply the gel once daily for a period of up to six weeks. Throughout the study, participants will have regular check-ins to monitor changes in their knee pain and overall health. The main focus will be on changes in pain levels after two weeks of treatment, using a specific pain measurement tool called the WOMAC pain sub-score.

In addition to the main treatment, participants may also receive Panodil, a medication containing paracetamol, which is commonly used to relieve pain. The study aims to provide valuable information on how well the new gel works in comparison to existing treatments and to ensure its safety for people with knee osteoarthritis. Participants will be closely monitored to track any changes in their condition and to ensure their well-being throughout the trial.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, participants will be informed about the study's purpose and procedures. Participants must provide written consent, confirming their understanding and willingness to participate.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes evaluating knee pain using the WOMAC pain sub-score, which is a questionnaire that measures pain levels in the knee.

  3. Step 3

    Medication administration

    Participants will be randomly assigned to receive either the diclofenac gel AMZ001 3.06% or a placebo gel. The gel should be applied topically to the affected knee once daily.

  4. Step 4

    Daily pain diary

    Participants are required to maintain a daily pain diary, recording their pain levels using an 11-point Numeric Rating Scale (NRS). This helps track changes in pain over time.

  5. Step 5

    Weekly assessments

    Weekly assessments will be conducted to evaluate changes in pain levels. This includes measuring the WOMAC pain sub-score and other related scores.

  6. Step 6

    Mid-trial evaluations

    At weeks 3 and 6, additional evaluations will be conducted to assess changes in pain, function, and quality of life. Participants will complete questionnaires such as the EQ-5D-5L to measure quality of life.

  7. Step 7

    Use of rescue medication

    Participants may use rescue medication if needed, and this usage will be recorded in the pain diary.

  8. Step 8

    End of trial

    The trial concludes with a final assessment to evaluate the overall change in pain and function. Participants will be informed of the study's outcomes and any next steps.

Who can join the trial?

11 criteria

  • The participant must be able to read and understand the study materials and agree to provide information during scheduled evaluations. They must also give written consent to participate.
  • The participant must have knee pain in the target knee for at least 14 days in the past month. This pain should be due to **osteoarthritis (OA)**, which is a type of arthritis that affects the knee, and not due to other conditions like bursitis or tendonitis.
  • Aside from having OA, the participant should be in reasonably good health as determined by the study doctor.
  • The participant must have **femorotibial OA** of the knee, which is a specific type of OA diagnosed using criteria from the American College of Rheumatology.
  • The participant's knee X-ray must show a **radiological OA grade** of 2 or 3, which is a way to measure the severity of OA using the Kellgren-Lawrence method.
  • The participant must be between 40 and 85 years old at the time of screening.
  • The participant's pain score for the target knee must be between 20 and 45 out of 50 on a specific pain scale called the **WOMAC pain sub-score**.
  • The pain score for the target knee must be higher than the pain score for the other knee, even if the other knee is not eligible for the study.
  • At the first screening visit, the participant must report that their typical OA knee pain, without medication, is at least 4 out of 10.
  • The participant must have an average daily OA knee pain score between 4 and 9 for the target knee in the week before the study starts. This average is based on at least 4 days of recorded pain scores.
  • Women who can have children must use a highly effective method of birth control, such as hormonal contraceptives or an intrauterine device, from the start of the study until at least 3 months after it ends. Men who are sexually active with a female partner who can have children must agree to use a condom during the same period.

Who cannot join the trial?

9 criteria

  • Patients who have any other joint disease besides knee osteoarthritis cannot participate.
  • Patients who have had surgery on the affected knee in the past 6 months are not eligible.
  • Patients who are currently using other treatments for knee pain that cannot be stopped during the study are excluded.
  • Patients with a known allergy to diclofenac or any of the ingredients in the study gel cannot join.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients with severe medical conditions that could interfere with the study are excluded.
  • Patients who have participated in another clinical trial in the last 30 days are not eligible.
  • Patients with a history of alcohol or drug abuse in the past year cannot participate.
  • Patients who cannot comply with the study procedures or follow-up visits are excluded.
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Investigated drugs

Diclofenac Gel AMZ001 is a topical medication used in this clinical trial to help relieve pain and symptoms associated with knee osteoarthritis. Osteoarthritis is a condition that causes joints to become painful and stiff. This gel is applied directly to the skin over the affected knee. It works by reducing substances in the body that cause pain and inflammation, helping to ease discomfort and improve movement in the knee. The trial aims to see how effective this gel is in reducing pain compared to a placebo, which is a substance with no active medication.

What is already known about the treatment

Diclofenac Gel AMZ001 3.06% – This medication is applied topically as a gel directly onto the skin over the affected knee area. It is currently being studied in clinical trials to assess its effectiveness and safety for treating knee osteoarthritis, a condition that causes joint pain and stiffness. Diclofenac works by reducing substances in the body that cause inflammation and pain, specifically by inhibiting enzymes called COX-1 and COX-2, which are involved in the production of inflammatory chemicals. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Investigated diseases

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease that affects the knee joint, leading to the breakdown of cartilage. As the cartilage wears away, bones begin to rub against each other, causing pain, swelling, and stiffness. Over time, the joint may lose its normal shape, and bone spurs may develop. The disease progresses gradually, with symptoms worsening over time. Movement becomes increasingly difficult, and the range of motion in the knee may decrease. The condition is more common in older adults and can be influenced by factors such as weight, genetics, and previous joint injuries.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517404-11-00Protocol codeAMZ001-007Estimated enrolment540 patientsSponsorAmzell B.V.

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