Clinical trials
A ‘clinical trial’ is a research study in which a potential new treatment is investigated to prevent, cure or improve a disease or medical condition. A clinical trial also looks at how participants react to the potential new treatment and if any unwanted effects occur. This helps to determine if the new investigational treatment works, is safe, and is better than those that are already available. Many clinical trials also compare existing treatments or test new ways to use or combine with existing treatments.
All new drugs must be tested in clinical trials before they can be prescribed to patients. Without people taking part in these research studies, we would have no new drugs to help others with their condition.
The OXTEND-03 clinical trial of Debio 4126 for patients with acromegaly
The OxtendTM-03 trial will be conducted in patients with acromegaly previously treated with somatostatin analogs. Somatostatin analogs are one of the treatment types that currently exist to treat acromegaly. They mainly include octreotide, lanreotide, and pasireotide.
The OxtendTM-03 clinical trial will assess the safety and efficacy of Debio 4126, an innovative injectable extended-release octreotide formulation. Debio 4126 was already tested in two completed clinical trials. Compared to the existing treatments typically administered every 4 weeks, Debio 4126 is injected less often (every 3 months). This is because Debio 4126 is released in the body over a longer period of time. Therefore, patients with acromegaly need fewer injections over their lifetime, while Debio 4126 is expected to work just as well and be just as safe as other somatostatin analogs.
In this clinical trial, participants will be randomly assigned to one of the 3 groups. Two groups will receive Debio 4126 while the third group will receive a placebo (a substance with no therapeutic effect).
You may be able to take part if:
- You have been diagnosed with acromegaly as per the definition of the trial protocol.
- You have been taking octreotide or lanreotide and no other acromegaly medications for at least 6 months, and your dose has not changed in the last 12 weeks.
- You never had pituitary gland radiotherapy.
- You are not planning pituitary gland surgery or radiotherapy.
- You are able and willing to adhere to study plan and procedures and use effective birth control methods.
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Phases
When a potential new medication is being developed, it is first tested in a laboratory setting. If the results are positive, the drug may enter a clinical trial program. This means that it will be tested in humans in several ‘phases’ of study.
Phase I = Safety evaluation. The very first administration in humans, typically carried out in a small group of healthy volunteers to assess if the drug is safe.
Phase II = Efficacy evaluation. The first trials in patients with the intended disease to check if the drug works efficiently and if there are any unwanted side effects.
Phase III = Confirming findings. Trials in large numbers of patients that generally compare the drug to the best treatments available.
_Phases
- P
- Ⅰ
- Ⅱ
- Ⅲ
- M
Talk with your medical doctor
If you are interested in participating in an upcoming clinical trial (can be also referred to as a clinical study), ask your doctor if a clinical trial might be right for you. Your doctor knows both you and your health history, which is invaluable in making this decision. Your doctor can help you gather the information needed to locate a trial and help you identify what questions might be important to ask the clinical trial doctor before deciding to participate.