Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 265 adults — 133 in the budesonide group and 132 in the placebo group. The trial was measuring how a medicine called budesonide compared to a dummy treatment (placebo) in people with ulcerative colitis. The main thing being measured was whether participants reached "remission" after six weeks — a combined assessment based on a colonoscopy score, the absence of rectal bleeding, and no worsening of how often they needed the toilet, all scored using a standard disease activity index. The reported data shows that after six weeks, 38.3% of participants in the budesonide group and 25.8% in the placebo group met the remission criteria. For the secondary measures, the reported figures were: no visible rectal bleeding at week 6 — 46.6% (budesonide) vs 28.0% (placebo); normal or only mildly abnormal colonoscopy score — 55.6% vs 43.2%; a combined symptom score meeting a specific low threshold — 41.4% vs 25.8%; and an overall disease score of 3 or less with meaningful improvement from the starting point — 45.9% vs 30.3%. The reported data also shows percentages of participants who had no rectal bleeding at various scheduled check-ins during the treatment period, ranging from roughly 6% to 21% in the budesonide group and 1.5% to 13.6% in the placebo group across those time points. It is worth noting that not everyone finished the trial — 108 of 133 people in the budesonide group and 116 of 132 in the placebo group completed it, and the reasons for not completing were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 27416045) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Crohn's Disease and Colitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are willing and able to sign a written consent form to participate.
- You are male, or a female who is not pregnant or breastfeeding.
- You have been confirmed by a camera procedure (endoscopy) to have active, mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis, with the affected area reaching at least 5 cm but no more than 40 cm from the opening of the rectum.
- Your disease activity score on a specific medical scale falls between 5 and 10 at the start of the trial (confirm with trial site).
Who may not be able to join:
- You have been diagnosed with, or have a history of, Crohn's disease or indeterminate colitis.
- You have had previous bowel or stomach surgery, except for appendix removal or hernia repair.
- You currently have another active digestive condition or an abnormal bowel structure.
- You have a history of diverticulitis, collagenous colitis, celiac disease, recurring pancreas problems, or known gallbladder disease.
- You have type 1 or type 2 diabetes that is not well controlled.
- You have a thyroid condition that is not well controlled.
- You have an unstable or serious heart, hormonal, neurological, or lung condition.
- Your blood count shows a haemoglobin level below 7.5 g/dL, indicating significant anaemia (confirm with trial site).
- You have a history of a specific liver condition called sclerosing cholangitis, liver scarring (cirrhosis), or reduced liver function.
- You have kidney disease shown by a specific blood test result above a certain level (confirm with trial site).
- You have a history of a specific hip bone condition, active tuberculosis, certain eye infections caused by herpes or chickenpox viruses, any cancer, or HIV, hepatitis B, or hepatitis C.
- You have a condition where your adrenal glands do not produce enough hormones.
- You currently have a serious infection anywhere in the body or skin, or serious bowel complications such as a severely swollen colon, a fistula, a hole in the bowel, or an abscess.
- You have a history of a mental health condition or seizure disorder that is not well controlled.
- You have a history of asthma that requires regular use of inhaled steroid medication.
- You have recently had problems with drug or alcohol misuse.
- Your stool test has come back positive for certain bacteria, a toxin called Clostridium difficile, or parasites.
- You have received a vaccination within 28 days before joining the trial.
- You have an allergy to budesonide (the study drug) or any of its ingredients.
- You have taken part in another clinical trial within the past 30 days.
- You are pregnant or there is a chance you could become pregnant during the trial.
- You are currently taking certain medications that are not allowed during the trial, including laxatives and anti-diarrhoea medicines, certain antibiotics, anti-seizure medications, and blood-thinning medications (some medicines are permitted — confirm the full list with the trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Percentage of Participants Who Achieved Remission
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.