A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase III Therapeutic Superiority Trial Comparing the Efficacy and Tolerability of a Fixed-Dose Combination of Diclofenac potassium + Thiocolchicoside to Diclofenac potassium (Cataflam®) in Patients with Acute Severe Low Back Pain.
This research study, called a Phase III trial, is investigating a new tablet that combines two medicines: diclofenac potassium (found in medications like Cataflam®) and thiocolchicoside. The main goal is to see if this combination is more effective at reducing severe low back pain than diclofenac potassium on its own. They are also comparing it to a dummy pill (placebo) and carefully checking for any side effects. Researchers will measure how much pain relief participants experience over a week and how well they can move. This type of study helps doctors understand the best ways to treat acute severe back pain.
At a glance
What is this study about?
Imagine you have really bad low back pain, the kind that makes it hard to do everyday things. Doctors are always looking for better ways to help people in this situation. This particular study is a careful investigation into a new tablet that combines two existing medicines: diclofenac potassium and thiocolchicoside. Diclofenac potassium is a common pain reliever, and thiocolchicoside helps relax muscles.
In this study, some people will receive the new combination tablet, others will get diclofenac potassium on its own (like Cataflam®), and a third group will receive a 'dummy' pill, called a placebo, which looks like the real medicine but contains no active ingredients. This helps researchers truly understand if the medicines are working because of their active ingredients or for other reasons. No one, not even the doctors giving out the medicine, will know who is getting what until the end of the study. This is called a 'double-blind' study and helps keep the results fair and unbiased.
The main aim is to see if the combination tablet provides better and longer-lasting pain relief over one week compared to taking diclofenac potassium alone. They're also carefully watching for any unwanted side effects. The results of this study will help healthcare professionals decide if this new combination could be a good treatment option for people suffering from acute severe low back pain in the future.
Key takeaways
- This study is testing a new combination medication for severe back pain.
- It aims to see if the combination works better than diclofenac alone.
- Participation involves taking medication for 7 days and reporting pain.
- You will not know if you're getting the active drug or a placebo.
- The study monitors both pain relief and potential side effects.
Who may be eligible?
To be able to take part in this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults can also participate.
This study is for people who are experiencing sudden and very bad low back pain. It's important that your pain is severe and has come on recently.
The selection process will also involve other health checks to make sure the study is safe for you and that the results will be meaningful. The study team will discuss all the requirements with 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 severe, acute (sudden) low back pain?
- Are you willing to take study medication for 7 days?
- Are you able to attend follow-up assessments?
What does participation involve?
If you decide to take part, you'll be given one of the study medications (the combination tablet, diclofenac potassium, or a placebo) to take for seven days. You won't know which one you're getting, and neither will the study doctors or nurses. Throughout this week, you'll be asked to regularly rate your pain levels.
You might also be asked to keep a diary or record how often you need to take any 'rescue medication' for pain that's not controlled by the study drug. At the beginning and end of the study week, you'll have specific tests, like checking how far you can bend to touch your toes (called a 'Finger-to-Floor Distance' test), to see if your back movement improves. The study team will carefully monitor you for any side effects throughout the 7-day period. Your total involvement in the study will last about one week.
Potential risks and benefits
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Common questions
What is a 'Phase III' trial?
This is a large study that compares a new treatment to existing ones or a dummy pill to see if it's safe and effective before it can be used more widely.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers understand if the medicine is truly working.
Will I know which medicine I'm getting?
No, this is a 'double-blind' study, meaning neither you nor the doctors will know which treatment you are receiving until the study is over.
How long will I be in the study?
Your active involvement with taking medication and assessments will last for 7 days.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and it will not affect your routine medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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