Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, multiple-dose, single-center, randomized, open-label, 2-period, 2-treatment crossover systemic bioavailability study of diclofenac comparing XXX g (XXX mL) of AMZ001 (Diclofenac sodium gel XXX %) applied once daily (XXXXXXXXX) versus XXX g of Voltaren Emulgel 1.16% Gel (Diclofenac diethylamine gel 1.16%) applied 4 times daily (4 times 4 g on each knee) in healthy subjects

This study is looking at a new version of diclofenac gel, a medicine used for muscle and joint pain. The new gel, called AMZ001, is being compared to a common gel called Voltaren Emulgel. Doctors want to see how much of the diclofenac medicine gets absorbed into the body when healthy adults use each gel. This is a "Phase 1" study, which means it's one of the first human tests, focusing on understanding how the new medicine works and if it's safe. It's hoped this new gel could be a useful treatment for conditions causing muscle and joint pain.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Amzell B.V.

Enrolment target

Start

04 Nov 2024

Phase I Study in healthy male and female volunteers. Intended indication: acute and chronic musculoskeletal conditions

What is this study about?

This research study is about a pain-relieving gel called diclofenac. Many people in the UK use diclofenac gel to help with aches and pains in their muscles and joints, like those from sprains or arthritis. This study is testing a new version of this gel, called AMZ001, to see if it works as well as, or better than, gels already available, such as Voltaren Emulgel.

The main goal is to understand how much of the diclofenac medicine from each gel gets into the body. This is important because it helps scientists understand if the new gel is being absorbed properly. They'll also be looking closely at how safe the new gel is and if there are any side effects. This type of study is called a 'Phase 1' study, which means it's one of the first times a new medicine is given to people, usually healthy volunteers.

By comparing the new AMZ001 gel with Voltaren Emulgel, which is a well-known product, researchers can get a clear picture of how the new gel performs. The hope is that this new gel could offer a convenient and effective way for people to manage pain from conditions affecting their muscles and joints, both short-term, like a sprain, and long-term, like arthritis.

Key takeaways

This study is testing a new diclofenac gel for muscle and joint pain.
It aims to see how much medicine gets into the body compared to an existing gel.
It's a 'Phase 1' study, focusing on safety and how the new gel works.
Healthy adults (18+) are needed to take part.
It involves applying gels and having blood tests at a clinic.

Who may be eligible?

To take part in this study, you need to be a healthy adult.

Both men and women can join, and you must be at least 18 years old. There isn't an upper age limit mentioned, but you'll need to be in good general health.

The study is looking for people who don't have any major medical conditions, as this is a 'Phase 1' study. This helps researchers understand the new medicine's effects without other health problems complicating the results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally in good health?
Are you comfortable with regular clinic visits and blood tests?
Are you willing to apply a gel medicine as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit a clinic regularly. This study involves using one type of diclofenac gel for a period and then switching to the other type. You'll apply the gels as instructed by the study team. For example, one gel might be applied once a day, and the other four times a day, though the exact amounts and frequencies will be explained in detail.

During your visits, the study team will take blood samples to measure how much of the diclofenac medicine is in your body. They'll also check your general health and ask about any side effects you might experience. The total length of your involvement in the study, including all treatments and follow-up checks, will be explained before you agree to take part.

Potential risks and benefits

Participating in this study might offer some potential benefits, as you'll receive careful medical supervision and free study medication. However, please remember that this is a research study, and the primary goal is to gather information about the new gel, not to provide personal medical treatment. As with any medication, there are potential risks, such as skin irritation where the gel is applied, or other side effects which will be explained to you in full. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is diclofenac gel used for?

It's a medicine often used to relieve pain and swelling in muscles and joints, like from sprains or arthritis.

What does 'Phase 1 study' mean?

It means this is one of the first times the new gel is being tested in healthy people to see how safe it is and how it works in the body.

Will I have to stay in the clinic?

The study is 'single-center', meaning all visits are at one location, but it doesn't specify if you need to stay overnight. You'll be told about the visit schedule.

What is the difference between the two gels being tested?

Both contain diclofenac, but one is a new formulation (AMZ001) and the other is a common gel (Voltaren Emulgel). The study compares how they deliver the medicine.

Will I get paid for taking part?

Studies sometimes offer payment or cover travel expenses. This will be explained in full if you're interested in joining.