COPE-CP: The effect of Celecoxib on pain, quality of life, use of opioids, and inflammation in patients suffering from chronic pancreatitis: a multicenter randomized placebo-controlled, double-blinded clinical trial
This study, called COPE-CP, is for people living with chronic pancreatitis, a condition that causes ongoing pain and affects daily life. Doctors want to see if celecoxib, a type of anti-inflammatory medicine, can help ease this pain more effectively than a dummy pill (placebo). They will measure how much pain people experience over 16 weeks, using special questionnaires. The study also investigates if celecoxib helps reduce the use of opioid painkillers, improves overall quality of life, and lessens inflammation in the body. Another aim is to see if it reduces hospital stays related to pancreatitis flare-ups, while also carefully checking for any side effects.
At a glance
What is this study about?
This research study, known as COPE-CP, is designed for people who have chronic pancreatitis. This is a long-term condition where the pancreas, an organ in your tummy, becomes inflamed, often leading to persistent pain and other problems. Living with chronic pancreatitis can be very challenging, so finding better ways to manage symptoms, especially pain, is really important.
The main goal of this study is to explore whether a medicine called celecoxib can help reduce the amount of pain people with chronic pancreatitis experience. Celecoxib is a type of anti-inflammatory drug that works by targeting certain chemicals in the body that cause pain and swelling. Researchers will compare celecoxib to a 'placebo' – which looks exactly like the study medicine but contains no active drug. This helps them understand if any changes are truly due to the medicine or other factors.
Beyond pain relief, the study also aims to understand how celecoxib might affect other important aspects of a person's life. This includes whether it can reduce the need for strong opioid painkillers, improve their general well-being and daily life (quality of life), and lower levels of inflammation in the body. They will also keep an eye on how often people need to go to hospital for pancreatitis flare-ups and monitor for any side effects of the medicine.
Key takeaways
- This study investigates celecoxib for pain relief in chronic pancreatitis.
- It also checks quality of life, opioid use, and inflammation levels.
- Participation involves taking daily medication (celecoxib or a dummy pill) for 16 weeks.
- Regular clinic visits include pain questionnaires, blood tests, and health checks.
- Both participants and doctors won't know which treatment is being given.
- All potential side effects will be closely monitored by the study team.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women can take part.
However, this is just a quick overview. There will be other specific health requirements and conditions that you must meet or not have, to ensure the study is safe and effective for everyone involved. For example, you might not be able to join if you have certain other medical conditions or are taking particular medications.
The research team will review your medical history carefully to confirm if this study is right for you. It’s always best to discuss your full medical situation with them and your doctor.
- Are you 18 years old or older?
- Do you have a diagnosis of chronic pancreatitis?
- Are you able to attend regular clinic appointments for 16 weeks?
- Are you comfortable taking study medication daily?
- Are you happy for your health and pain levels to be regularly monitored?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be given either the study medicine (celecoxib) or a dummy pill (placebo), along with another medication called pantoprazole, which helps protect your stomach. You won't know which treatment you are receiving, and neither will your study doctor, to keep the results fair and unbiased. The main treatment period will last for 16 weeks.
Throughout these 16 weeks, you will have regular visits to the clinic. During these visits, the research team will ask you questions about your pain using special questionnaires, measure your blood to check inflammation levels, and ask about any other medications you are taking, especially pain relief. They will also check your overall health and well-being, and keep track of any hospital visits related to your pancreatitis.
After the 16-week treatment, there will likely be further follow-up appointments to check on your health and any long-term effects. The total duration of your participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What is chronic pancreatitis?
Chronic pancreatitis is a long-lasting condition where your pancreas, an organ that helps with digestion and blood sugar, becomes inflamed and can cause ongoing pain and other problems.
What is celecoxib?
Celecoxib is a medicine that helps reduce pain and inflammation. It's a type of non-steroidal anti-inflammatory drug (NSAID).
Why will some people get a dummy pill?
Some people will receive a dummy pill (placebo) so researchers can accurately compare the effects of celecoxib against no active treatment. This helps ensure that any benefits seen are truly due to the medicine.
How long will the treatment last?
The main treatment period for this study will last for 16 weeks, with regular check-ups during that time.
What is 'double-blinded'?
Being 'double-blinded' means neither you nor your study doctor will know whether you are receiving celecoxib or the dummy pill. This helps keep the study fair and unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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