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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
Study Summary
This trial will assess how safe and effective mesalamine delayed-release capsules are in treating pediatric participants with UC.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Maintaining Clinical Remission Responder Status Based on the modified Mayo Score (mMS)
Secondary outcome measures
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%
Upper respiratory infection
3%
Fatigue
3%
Nausea
3%
Reflux
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
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
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
502,304 Total Patients Enrolled
30 Trials studying Ulcerative Colitis
21,374 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,018 Total Patients Enrolled
16 Trials studying Ulcerative Colitis
16,260 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At what age does this research project cutoff volunteers?
"To be clear, this trial is only for children aged 5-17. There are currently 70 active clinical trials for individuals under 18 and 364 for people over the age of 65."
Answered by AI
Are people with the required medical condition still being enrolled in this trial?
"According to the latest information from clinicaltrials.gov, this particular trial is not enrolling patients. Although, it was first posted on 6/13/2022, and was last edited on 5/17/2022, there are 425 other trials that are still currently looking for patients to enroll."
Answered by AI
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