A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission.
Ulcerative colitis causes inflammation and sores in the lining of the large bowel, leading to tummy pain, frequent diarrhoea, and bleeding. Mesalazine is a standard medicine used to treat flare-ups by reducing swelling in the gut. This clinical trial compares a new mesalazine tablet to an established, trusted brand called Claversal. The goal is to confirm whether the new tablet works just as well at helping symptoms settle into remission. Participants will take study tablets each day for eight weeks. Because this is a fair comparison study, every participant receives real mesalazine alongside dummy tablets to keep the test unbiased. Specialist doctors will track symptoms, test stool samples, and perform camera checks of the bowel to see how well the gut heals. The trial aims to provide another reliable treatment option for adults living with active ulcerative colitis.
At a glance
What is this study about?
Ulcerative colitis is a long-term condition where parts of the bowel become swollen and inflamed. During a flare-up, everyday life can be disrupted by frequent, urgent trips to the toilet, tummy cramps, and rectal bleeding. Mesalazine belongs to a well-known group of anti-inflammatory medicines called 5-ASAs. It works directly inside the gut to soothe irritated tissue and help the bowel lining heal.
While mesalazine is already widely prescribed, pharmaceutical scientists continue to develop new tablet formulations to give patients more effective or convenient choices. This Phase 3 trial compares a new oral formulation of mesalazine against Claversal, an established mesalazine brand already used in clinics. The study aims to show that the new tablet is just as good as the existing one at bringing active colitis under control.
To ensure fair results, the trial uses a 'double-blind, double-dummy' design. This means neither you nor your medical team will know which brand you are taking, and everyone takes an active tablet of one type plus a matching dummy (placebo) tablet of the other. That way, nobody misses out on active treatment. Over eight weeks, doctors will monitor your bowel health to see if your inflammation clears up and your symptoms disappear completely.
Key takeaways
- Tests a new daily mesalazine tablet for mild to moderate ulcerative colitis flare-ups.
- The treatment period lasts for eight weeks to see if it helps symptoms settle into remission.
- All participants receive real, active mesalazine; no one receives only a dummy tablet.
- Doctors will track bowel healing using symptom diaries, stool samples, and camera checks.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with mild to moderate ulcerative colitis. To be eligible, you must currently be experiencing active flare-up symptoms, such as regular loose stools or bleeding from the back passage.
Men and women of any background can take part. However, this study might not be right for you if your colitis is severe, if you have complications that require urgent surgery, or if you have known allergies to mesalazine or aspirin-like medicines.
Before you can join, the study doctor will carry out health checks and review your medical history. This makes sure that your current symptoms fit the trial guidelines and that taking part is safe for 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.
- You are aged 18 or older.
- You have a confirmed diagnosis of ulcerative colitis.
- You are currently having mild to moderate flare-up symptoms, such as loose stools or bleeding.
- You can take daily tablets by mouth.
- You are willing to attend hospital visits and have bowel camera tests (endoscopies).
What does participation involve?
Taking part in the study lasts for about eight weeks. During this time, you will take study tablets by mouth every day. Because of the study design, you will take both a real mesalazine tablet and a dummy tablet daily, guaranteeing that you receive real medicine while keeping the test fair. You will visit the hospital clinic several times for regular health checks. These appointments include physical exams, blood tests, and stool tests to measure inflammation. You will also answer simple questions about your daily bowel habits and quality of life. At the start and end of the eight weeks, you will have an endoscopy (a small camera test to look inside your bowel) so doctors can examine your bowel lining and check for healing.
Potential risks and benefits
Locations (7)
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Common questions
Will I receive real medicine or just a dummy pill?
You will definitely receive real mesalazine. Dummy tablets are only used alongside real tablets so nobody knows which brand they have, but every patient gets active treatment.
How long will I be in the study?
The treatment period lasts for eight weeks, along with an initial screening visit and a short follow-up check at the end.
What tests will I need to have?
You will have routine blood and stool tests, answer symptom questions, and have two camera checks (endoscopies) to look directly at your bowel lining.
Can I leave the study if I change my mind?
Yes. You can leave the study at any point. Your decision will not change your relationship with your doctor or your access to standard NHS care.
Do I have to pay to take part?
No. The trial medicine and clinic visits are free, and you may be able to get help with travel costs to and from the hospital.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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