A Phase 3, open-label, single-arm, multi-center trial to assess the long-term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly
This research study is for adults who have acromegaly, a condition where your body makes too much growth hormone. We are testing a new way to deliver a medicine called octreotide, which is given as a depot injection under the skin. This study is mainly focused on checking how safe this new treatment is over a long period. We will carefully watch for any side effects and see how people feel. We also want to understand how well the medicine controls hormone levels and improves daily life, including comfort and satisfaction with the treatment. The study has a main part and an extension part, meaning some people will continue to be monitored for an even longer time.
At a glance
What is this study about?
Acromegaly is a condition where the body produces too much growth hormone. This can lead to larger hands and feet, changes in facial features, and other health problems if not managed. Medicines like octreotide are often used to help control these hormone levels.
This particular study is looking at a new way to give octreotide. Instead of daily injections, this new version is given as an injection under the skin that slowly releases the medicine over time. The main goal of this study is to see how safe this new treatment is when used for a long time. The researchers will be very careful in checking for any unwanted effects or health changes in the people taking part.
Beyond safety, the study also aims to understand how well this new treatment works to keep growth hormone levels stable. It will also look at how taking this medicine might affect a person's quality of life, including their general well-being, how convenient they find the treatment, and their overall satisfaction with it. By gathering this information, doctors hope to offer better and more comfortable treatment options for people living with acromegaly.
Key takeaways
- This study evaluates a potentially more convenient treatment for acromegaly.
- The primary focus is on the long-term safety of the new medicine.
- It also assesses how well the treatment controls hormone levels and improves quality of life.
- Participants will receive regular medical check-ups and the study medicine.
- It involves self-administered injections after training.
Who may be eligible?
This study is designed for adults aged 18 and over who have been diagnosed with acromegaly. Both men and women are welcome to take part.
Before joining, a healthcare professional will carefully check your medical history to make sure this study is right for you and that you meet all the specific health requirements. This is to ensure your safety and that the study results are clear.
If you're interested, your doctor can help determine if your specific health situation matches what the researchers are looking for. There are often other medical conditions or medications that might prevent someone from joining, even if they have acromegaly and are an adult.
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?
- Have you been diagnosed with acromegaly?
- Are you willing to have regular clinic visits and blood tests?
- Are you able to or have a partner willing to learn how to give injections at home?
What does participation involve?
If you join this study, you'll receive the new octreotide medicine as an injection under the skin. You'll have regular visits to the clinic, which will involve check-ups, blood tests to measure hormone levels, and discussions about how you're feeling and any side effects. You might also be asked to fill out questionnaires about your quality of life and how satisfied you are with the treatment.
The study has a 'main part' lasting about a year, and then some participants may continue into an 'extension part' for an even longer time. This means you could be involved in the study for a significant period. You'll be taught how to give yourself the injection, or a partner could be taught, so you can manage your treatment at home between clinic visits. Throughout the study, various tests like heart readings (ECG) and scans of your gallbladder will be done to monitor your health.
Potential risks and benefits
Locations (5)
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedPoland
Common questions
What is acromegaly?
Acromegaly is a condition where your body makes too much growth hormone, causing parts of your body, like your hands and feet, to grow larger.
What is CAM2029?
CAM2029 is a new way of giving a medicine called octreotide, which helps control growth hormone levels in people with acromegaly. It's given as an injection under the skin that lasts longer.
Why is this study being done?
This study wants to check how safe this new medicine delivery method is over a long time and how well it helps manage acromegaly and improve patients' lives.
Will I have to give myself injections?
Yes, you or a trained partner will likely be taught how to give the injections at home between your clinic visits.
How long will I be in the study?
The study has a main part of about a year, and some people may continue into an extension part, meaning you could be in the study for a longer period.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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