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Aminosalicylate
Mesalamine for Ulcerative Colitis
Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights
Pivotal Trial
Summary
This trial is testing mesalamine capsules to see if they are safe and effective for children with Ulcerative Colitis. The medication helps reduce inflammation in the colon. About 80 children will take the capsules regularly for several months, and their health will be monitored through regular check-ups and tests. Mesalamine has been shown to be effective in maintaining remission in ulcerative colitis and is well-tolerated.
Who is the study for?
This trial is for children aged 5 to 17 with Ulcerative Colitis (UC) who have been in remission for at least 30 days and are on a stable dose of mesalamine or equivalent. They must not have significant abnormal results in physical exams, medical history, ECG, blood tests, or urinalysis.
What is being tested?
The study is testing the safety and effectiveness of mesalamine capsules compared to a placebo in treating UC in kids. Participants will be randomly assigned to one of two groups and take the treatment twice daily for 26 weeks with follow-up.
What are the potential side effects?
Possible side effects include digestive issues like stomach pain, diarrhea, nausea; headache; rash; fatigue. The severity can vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS)
Secondary study objectives
Percentage of Participants Maintaining Endoscopic Remission Responder Status Based on the mMS
Percentage of Participants Maintaining Symptomatic Remission Responder Status Based on the mMS
Side effects data
From 2019 Phase 3 trial • 61 Patients • NCT0141237210%
light headed/dizziness
6%
Increased bowel movement
6%
Abdominal Pain
6%
Sinusitis
3%
Reflux
3%
Upper respiratory infection
3%
Fatigue
3%
Nausea
3%
Sharp pain
3%
Motion Sickness
3%
Bloating
3%
Swelling
3%
Weight Gain
3%
Fever
3%
Hematochezia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mesalamine
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Mesalamine Dose BExperimental Treatment2 Interventions
Participants will receive mesalamine Dose B twice daily for 26 weeks.
Group II: Mesalamine Dose AExperimental Treatment1 Intervention
Participants will receive mesalamine Dose A twice daily for 26 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesalamine
2016
Completed Phase 4
~2010
Placebo
1995
Completed Phase 3
~2670
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Mesalamine, a 5-aminosalicylate, inhibits the production of inflammatory chemicals in the colon, reducing inflammation and promoting healing of the colonic lining. This is vital for Ulcerative Colitis patients as it directly addresses the inflammation that causes symptoms like diarrhea, rectal bleeding, and abdominal pain.
Other treatments, such as sulfasalazine (a prodrug of 5-ASA) and glucocorticoids, also reduce inflammation through different mechanisms, providing options based on disease severity and patient response.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,017 Previous Clinical Trials
519,946 Total Patients Enrolled
32 Trials studying Ulcerative Colitis
22,286 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
441 Previous Clinical Trials
160,581 Total Patients Enrolled
18 Trials studying Ulcerative Colitis
17,172 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Ulcerative Colitis in remission for 30+ days and am on a stable dose of mesalamine.
Research Study Groups:
This trial has the following groups:- Group 1: Mesalamine Dose A
- Group 2: Mesalamine Dose B
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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