A Randomized, Multicentre, Double-blind, two Parallel Group, Clinical Phase III Trial for Comparing the Efficacy and Tolerability of a combination IM product of Diclofenac and Thiocolchicoside vs. Diclofenac (Voltaren®) IM in patients with acute moderate to severe low back pain
This study is a research project focusing on people who have sudden, moderate to severe lower back pain. Researchers are testing a new combined injection treatment that contains two medicines: Diclofenac and Thiocolchicoside. This new combination is being compared to a standard treatment, Diclofenac (known as Voltaren®) given as an injection, to see if the new combination works better. The main aim is to find out how much pain relief patients get within three hours of having the injection. They will also look at how quickly pain improves, how many people have a significant reduction in pain, and whether the treatment helps with movement. Safety is also very important, so researchers will track any side effects or reasons why people stop taking part in the study. This is a Phase 3 study, meaning it's a key step in testing potential new medicines before they can become widely available.
At a glance
What is this study about?
This research study is looking for volunteers who are experiencing acute, or sudden, lower back pain that is moderate to severe. Acute means the pain has come on recently, not pain that has lasted a long time.
The main goal of the study is to see if a new combination of two medicines given by injection works better than diclofenac (which you might know as Voltaren®) given on its own as an injection. The two medicines in the new combination are diclofenac and thiocolchicoside. Doctors want to know which treatment is better at reducing pain quickly and if the new combination is safe and well-tolerated by patients.
This is a 'Phase 3' study. This means it's one of the final stages of testing a new treatment before it can be considered for wider use. Researchers will be carefully comparing the two treatments to understand their effects on pain, movement, and any side effects patients might experience. By taking part, you could help doctors learn more about effective ways to treat lower back pain.
Key takeaways
- This study evaluates a new treatment for sudden, moderate to severe lower back pain.
- It compares a new combination injection to a standard pain relief injection.
- The main goal is to find out which treatment provides better and faster pain relief.
- Safety and side effects of both treatments will be closely monitored.
- You won't know which specific treatment you receive for a fair comparison.
- Participation involves receiving an injection and a few short assessments.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can take part as well.
Both men and women are welcome to participate in this research. The most important thing is that you are currently experiencing sudden, moderate to severe lower back pain.
The research team will have a more detailed list of things that decide if you can join, such as your general health, other medical conditions, and any medicines you are currently taking. They will check these thoroughly to make sure the study is right 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?
- Are you experiencing sudden, moderate to severe lower back pain?
- Are you able to attend appointments for assessments after the injection?
- Are you willing to potentially receive either the new combination drug or the standard treatment?
- Do you understand that you will be closely monitored for any side effects?
What does participation involve?
If you decide to take part, you will receive an injection of one of the study medicines. Neither you nor your study doctor will know if you are getting the new combination or the standard diclofenac injection; this is to ensure the results are fair and unbiased. Your pain levels will be measured by asking you about your pain and also by checking how easily you can move, for example, by seeing how far you can reach towards the floor.
Assessments will happen before the injection and at specific times afterwards, mainly at 1 hour and 3 hours post-injection. The total duration of your active participation in the study will be quite short, mainly focused on monitoring your pain and any effects of the medicine within the first few hours after the injection. There will also be a follow-up to check on your well-being.
Potential risks and benefits
Locations (1)
- —UnverifiedGreece
Common questions
What kind of back pain is this study for?
This study is for sudden, moderate to severe lower back pain that has come on recently, not long-term back pain.
Will I know which medicine I'm getting?
No, neither you nor your doctor will know if you're getting the new combination or the standard medicine. This is to ensure fair results.
How long will I be involved in the study?
Your active participation will mostly involve assessments around the time of the injection, especially within the first three hours. There will also be a follow-up check.
What are they hoping to find out?
Researchers want to see if the new combination medicine reduces pain more effectively and safely than the standard medicine for lower back pain.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.