A phase 2, multicenter, randomized, double blind, active controlled, parallel group study assessing the analgesic effect and safety of two doses of DFL24412 in patients with chronic low back pain compared to Ketoprofen Lysine Salt (KLS)
This research study is looking into a new medicine, DFL24412, for people who have had ongoing lower back pain. It's a 'Phase 2' study, which means it's still in the early stages, focusing on whether the medicine works and if it's safe. Participants will be given either one of two doses of DFL24412 or a standard painkiller called Ketoprofen Lysine Salt (KLS) to see how well they relieve pain. Researchers will measure pain levels, impacts on daily life, and any side effects. This study aims to find out if DFL24412 could be a helpful new treatment option for chronic lower back pain. Participants will take medication and have their progress checked over a few weeks.
At a glance
What is this study about?
This study is a medical research project focusing on people who experience ongoing lower back pain. Many people live with this kind of pain, and researchers are always looking for new and effective ways to help manage it. This particular study is investigating a new medicine called DFL24412. It's a 'Phase 2' study, which is an important step in developing new treatments. In this phase, doctors want to learn if the medicine is effective at reducing pain and if it's safe for people to use. It's not the final step before a medicine becomes widely available, but it gives valuable information.
To understand how DFL24412 works, participants will be put into different groups by chance (like flipping a coin). Some will receive one of two different doses of DFL24412, while others will receive a commonly used painkiller called Ketoprofen Lysine Salt (KLS). Neither the participants nor their doctors will know which treatment they are receiving until the study is over. This is done to make sure the results are as fair and accurate as possible.
The main goal is to see how much people's lower back pain levels change after taking the medicine for a week. Researchers will use a simple pain scale, where you rate your pain from 0 (no pain) to 10 (worst possible pain). They will also look at other important things, like how the pain affects daily activities, mood, and overall quality of life. Safety is also a top priority, so they will carefully track any side effects or changes in your health. By comparing DFL24412 to an existing treatment, scientists hope to learn if it could offer a new and better option for managing chronic lower back pain in the future.
Key takeaways
- It's a study for adults with long-lasting lower back pain.
- Compares a new medicine (DFL24412) to existing painkillers.
- Aims to check if the new medicine reduces pain and is safe.
- Participation involves taking medication and regular health checks.
- The study lasts about three weeks, including follow-up.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part.
The most important thing is that you have ongoing, long-lasting lower back pain that has been bothering you for a while. The researchers are looking for people who fit specific criteria for their pain, to make sure the study results are clear and applicable to the right group of patients. During the screening process, the study team will ask you questions and perform some checks to confirm you meet all the necessary requirements.
There might be other health conditions or medicines that would prevent you from joining, as these could affect the study's safety or results. The study team will discuss all of these with you in detail to make sure this study is right and safe for you.
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?
- Do you have chronic (long-lasting) lower back pain?
- Are you able to attend clinic visits and complete questionnaires?
- Do you understand that you might not know which medicine you are taking?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of four groups to receive one of the study medications: TACHIPIRINA (500mg), OKi (80mg), or one of two different strengths of KLS-GABA (40mg-17mg or 80mg-34mg). You will take the medication as instructed.
Over the course of the study, you'll have several visits or assessments. The main treatment period is for about one week. During this time, you will be asked to regularly rate your daily lower back pain intensity using a simple number scale. You'll also complete questionnaires about your pain, how it affects your daily life, and your mood, such as anxiety and depression.
There will be check-ups at the study clinic where the research team will perform physical examinations, check your vital signs (like blood pressure and heart rate), and take blood and urine samples for safety tests. These tests help them check how your body is responding to the treatment. There will also be a follow-up visit around Day 21 after you start the medication.
The total duration of your active involvement in the study, including the treatment period and follow-up, will be around three weeks. You will also be monitored for any side effects throughout this time.
Potential risks and benefits
Locations (2)
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is 'chronic low back pain'?
It means long-lasting lower back pain, usually pain that has been present for three months or more.
What does 'Phase 2' mean for a medicine?
It means the medicine is in an early stage of testing. Researchers are mainly looking to see if it works and if it's safe for people, rather than just assessing its safety.
Will I know which medicine I'm taking?
No, in this type of study, neither you nor your doctor will know which medicine you're taking. This helps ensure the results are unbiased and accurate.
How will my pain be measured?
You'll be asked to rate your average daily lower back pain using a simple number scale, usually from 0 (no pain) to 10 (worst pain).
How long will I be involved in the study?
Your involvement, including treatment and follow-up, will be for approximately three weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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