Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02093663 | Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis | PHASE3 | COMPLETED | 107 | — | — | Dec 12, 2014 | Nov 28, 2018 | Jun 9, 2021 | 33 | United States, Canada +5 |
| NCT01130844 | Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis | PHASE1 | COMPLETED | 52 | — | — | Oct 8, 2010 | Jun 27, 2013 | Jun 14, 2021 | 19 | United States, Australia +3 |
Clinical response was defined as partial ulcerative colitis disease activity index (UC-DAI) score \< or =1 with rectal bleeding = 0, stool frequency \< or =1, and physician's global assessment (PGA = 0). Number of participants with clinical response were reported.
Clinical response was defined as partial UC-DAI \<=1 with (rectal bleeding = 0, stool frequency \< or =1, and PGA = 0). Number of participants who had maintained clinical response were reported.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Clearance of a substance from the blood by the kidneys.
| Arm | Type | Description |
|---|---|---|
| MMX Mesalamine/Mesalazine (Low Dose) | EXPERIMENTAL | Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (\<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (\>) 23 kg to \<= 35 kg; 1800 mg/day for participants weighing \> 35 kg to \<= 50 kg; 2400 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine/Mesalazine (High Dose) | EXPERIMENTAL | Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to \<= 23 kg; 2400 mg/day for participants weighing \> 23 kg to \<= 35 kg; 3600 mg/day for participants weighing \> 35 kg to \<= 50 kg; 4800 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine (30mg/kg) | EXPERIMENTAL | - |
| MMX Mesalamine (60 mg/kg) | EXPERIMENTAL | - |
| MMX Mesalamine (100 mg/kg) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MMX Mesalamine/Mesalazine (Low Dose) | DRUG | Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (\<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (\>) 23 kg to \<= 35 kg; 1800 mg/day for participants weighing \> 35 kg to \<= 50 kg; 2400 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine/Mesalazine (High Dose) | DRUG | Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to \<= 23 kg; 2400 mg/day for participants weighing \> 23 kg to \<= 35 kg; 3600 mg/day for participants weighing \> 35 kg to \<= 50 kg; 4800 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine | DRUG | 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
Inclusion Criteria: 1. Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative \[LAR\]) informed consent or assent as applicable to participate in the study. 2. Subject's parent/LAR demonstrates an understanding, ability, and willingness to f...