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 52 children and young people in total, divided into three groups based on their dose of a medication called MMX Mesalamine (also known as 5-ASA): 21 participants received 30 mg per kilogram of body weight, 22 received 60 mg per kilogram, and 9 received 100 mg per kilogram. All 52 participants who started the study completed it. The trial was primarily measuring how the drug moves through the body — specifically how much of it enters the bloodstream, how high the concentration gets, how quickly that peak is reached, and how fast the body clears it. A secondary measure looked at how much of the dose could be detected in urine. The reported data shows that the overall drug exposure in the blood (measured as "area under the curve," which is a way of capturing both how much drug was present and for how long) was 21,411 units in the lowest-dose group, 46,173 in the middle-dose group, and 49,213 in the highest-dose group. The peak blood concentration reached was reported as 1,884 units, 3,825 units, and 4,314 units for the three groups respectively. The time it took to reach that peak was reported as 6.0 hours, 8.98 hours, and 1.98 hours. The rate at which the body cleared the drug was 6.48, 5.94, and 4.95 litres per hour across the three groups. Similar exposure figures were also reported for the drug's main breakdown product in the body. The reported data shows that the proportion of the dose that was absorbed and detected in urine was 29.4% for the lowest-dose group, 27.0% for the middle-dose group, and 22.1% for the highest-dose group. No other secondary outcome figures were included in the submitted results data. 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 26893546) ↗
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 1 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:
- Children and teenagers between the ages of 5 and 17 years old, with permission given by both the parent/guardian and the child themselves.
- You have been diagnosed with ulcerative colitis for at least 3 months.
- If you are currently taking a medication called 5-ASA (or a medication that works like it), you must have been on the same dose for at least 4 weeks before the trial starts.
- If you are not currently on any medication, or are only on a 5-ASA-type medication, your treatment routine must have been stable for at least 4 weeks before the trial starts.
- Your body weight is between 18 kg (about 40 lbs) and 82 kg (about 181 lbs).
Who may not be able to join:
- You have a current or recurring condition affecting the heart, kidneys, liver, or another serious illness (other than ulcerative colitis) that could interfere with the trial or its medication (confirm with trial site).
- Your ulcerative colitis only affects the very end part of the bowel (the rectum), with no involvement further up.
- You have a history of liver problems or moderate to severe kidney problems.
- You have used steroid medications (taken by mouth or applied rectally) in the last 4 weeks, immune-suppressing drugs in the last 6 weeks, biologic medications in the last 6 months, or antibiotics in the last 7 days before the trial begins.
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.
Contact this trial
Principal Investigator: Study Director, Takeda
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State; Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State; Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State; Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State; AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State; Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State; Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State; CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady...
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.