A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants with Exocrine Pancreatic Insufficiency.
This study is investigating a new medicine called NHS7108 for people who have Exocrine Pancreatic Insufficiency (EPI). EPI is a condition where your body doesn't produce enough enzymes to digest food properly, leading to problems like bloating and diarrhoea. The study is comparing different amounts (doses) of NHS7108 to an existing medicine, Zenpep, which is already used to treat EPI. Researchers want to find out how safe NHS7108 is and how well it helps people digest their food. They will look at how it affects side effects, digestion, and general health over a 14-day period.
At a glance
What is this study about?
This clinical trial is for people who have a condition called Exocrine Pancreatic Insufficiency, often shortened to EPI. If you have EPI, your pancreas doesn't make enough special chemicals called enzymes. These enzymes are vital for breaking down the food you eat so your body can absorb important nutrients. Without enough enzymes, you might experience symptoms like uncomfortable bloating, tummy pain, weight loss, and stools (poo) that are hard to flush.
The main aim of this study is to test a new potential medicine called NHS7108. The researchers want to see if NHS7108 can help people with EPI digest their food better. They are also comparing it to a medicine that is already approved and used for EPI, called Zenpep. By doing this, they hope to understand how well NHS7108 works and if it's safe to use.
During the study, participants will try different doses of NHS7108 and also Zenpep. The doctors will carefully check for any side effects and monitor how well the medicines are helping with digestion. This includes looking at general health, how fats are absorbed from food, and any changes in tummy symptoms. The information gathered will help decide if NHS7108 could be a good new treatment option for EPI in the future.
Key takeaways
- This study is for adults with Exocrine Pancreatic Insufficiency (EPI).
- It tests a new medicine (NHS7108) against an existing one (Zenpep).
- The main goals are to check for safety and how well the new medicine helps digestion.
- Participation involves taking medicines and attending clinic visits for checks.
- You'll be asked to record your symptoms in an electronic diary.
- Your health will be closely monitored by the study team.
Who may be eligible?
To join this study, participants must be adults, meaning 18 years old or older. The study is open to both men and women.
Because this study focuses on Exocrine Pancreatic Insufficiency, you would need to have this specific condition to be considered. The research team will carefully check your medical history to make sure the study medication is suitable and safe for you.
It's important to remember that these are just the basic requirements. There might be other specific health factors that the study doctors will consider before you can take part. They will discuss all the details 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?
- Have you been diagnosed with Exocrine Pancreatic Insufficiency (EPI)?
- Are you able to attend regular clinic visits?
- Are you comfortable using an electronic diary to track symptoms?
What does participation involve?
If you decide to take part in this study, you'll be trying different medicines. This includes a new medicine called NHS7108 and also Zenpep, a medicine already used for EPI. You won't know which medicine you're taking at certain times, and neither will the study team during specific parts of the trial. This helps make sure the results are fair.
The study involves several visits to the clinic over a period of time. During these visits, the medical team will carry out various checks. This includes taking blood and urine samples, checking your blood pressure and heart rate, doing an electrocardiogram (ECG) to look at your heart, and performing physical examinations. They will also ask you to fill in an electronic diary (eDiary) to record your symptoms, like how often you have a bowel movement and what your stools look like (using a simple scale).
Each period of taking the study medicine will last for 14 days. This is a "crossover" study, which means you might try NHS7108 for a period and then switch to Zenpep for another period, or vice versa, with a break in between. The total length of your participation in the study, including all treatment periods and follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (5)
- —UnverifiedPoland
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedBulgaria
- —UnverifiedItaly
Common questions
What is Exocrine Pancreatic Insufficiency (EPI)?
EPI is a condition where your pancreas doesn't make enough enzymes to properly digest the food you eat, leading to problems like indigestion and poor nutrient absorption.
What is the new medicine, NHS7108?
NHS7108 is a new type of medicine being tested to help people with EPI digest their food better. It's a lipase enzyme replacement.
Will I know which medicine I'm getting?
For parts of this study, you might not know if you're taking NHS7108 or Zenpep. This is done to ensure the study results are as unbiased as possible.
How long will the study medicine periods last?
Each time you take a study medicine, it will be for a period of 14 days. The study has different treatment periods.
Can I stop participating if I want to?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting 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.