Mesalamine for Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of delayed-release mesalamine capsules for treating children with ulcerative colitis (UC), a disease that causes ongoing inflammation in the colon. Participants will be divided into two groups to receive different doses of mesalamine twice a day for 26 weeks. The study includes regular check-ups, such as medical assessments, blood tests, and questionnaires, to monitor the treatment’s impact and any side effects. Children aged 5 to 17 with UC who are currently stable on mesalamine or a similar medication might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to advancing treatment options for UC.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on a stable dose of mesalamine or a similar medication before joining the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mesalamine is generally safe for people with ulcerative colitis. One study found that a higher dose of mesalamine is as safe as a lower dose, indicating that more of the drug doesn't necessarily lead to more side effects. Another study confirmed mesalamine's safety for children and teens with mild-to-moderate ulcerative colitis.
In trials involving thousands of patients with inflammatory bowel disease, most of whom had ulcerative colitis, mesalamine was well-tolerated. Common side effects included mild stomach pain, headache, and diarrhea, which were usually not severe.
Although mesalamine is approved for ulcerative colitis, its safety in children under five years old hasn't been fully studied. However, this trial targets children aged five and older. Overall, the evidence suggests that mesalamine is a safe treatment for ulcerative colitis in older children and teens.12345Why are researchers excited about this trial's treatments?
Researchers are excited about mesalamine for ulcerative colitis because it offers a targeted approach to reducing inflammation in the colon. Unlike some standard treatments that may involve steroids or biologics, mesalamine works directly in the gut to inhibit substances that cause inflammation, potentially leading to fewer systemic side effects. This treatment is administered in two different dosages, Dose A and Dose B, allowing flexibility in managing the condition based on individual patient needs. This focused mechanism and customizable dosing strategy make mesalamine a promising option in the management of ulcerative colitis.
What evidence suggests that this trial's treatments could be effective for ulcerative colitis?
Research has shown that mesalamine effectively treats ulcerative colitis (UC), particularly in mild to moderate cases. Studies have found that mesalamine can control symptoms and outperforms a placebo. In one study, 70.9% of patients remained symptom-free after one year of using mesalamine. Doctors often recommend it as the first treatment for UC, and most people tolerate it without serious side effects.
In this trial, participants will receive either Mesalamine Dose A or Mesalamine Dose B to evaluate the effectiveness of different dosages.678910Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral mesalamine capsules twice daily for 26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mesalamine
- Placebo
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive mesalamine Dose B twice daily for 26 weeks.
Participants will receive mesalamine Dose A twice daily for 26 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Published Research Related to This Trial
Citations
Effectiveness of Mesalamine in Patients With Ulcerative ...
Oral 5-ASA induces remission and clinical improvement better than a placebo in active mild-to-moderate UC. Nine patients were treated to improve ...
MMX mesalamine in ulcerative colitis: Major advantages ...
Clinical trials demonstrated a strong efficacy in inducing and maintaining clinical and endoscopic remission in active mild-to-moderate UC. The efficacy is ...
Optimizing 5-aminosalicylate for moderate ulcerative colitis
At year 1, the study found that 70.9% of patients who received a daily dose of 2 g 5-ASA maintained remission, while only 58.9% of patients who ...
The continuing value of mesalazine as first-line therapy for ...
The evidence presented demonstrates that mesalazine has a well-supported history as effective and well-tolerated first-line therapy for patients ...
Oral Mesalamine (Asacol) for Mildly to Moderately Active ...
Results: The analysis of protocol-compliant patients showed a significant improvement at 3 weeks in patients taking 2.4 g/d of mesalamine compared with ...
Asacol® (mesalamine) Delayed-Release Tablets
ADVERSE REACTIONS: Asacol tablets have been evaluated in 3685 inflammatory bowel disease patients (most patients with ulcerative colitis) in controlled and open ...
Mesalamine (oral route) - Side effects & dosage
Safety and efficacy have not been established in children younger than 5 years of age and for the prevention of ulcerative colitis in children.
Systematic review: safety of mesalazine in ulcerative colitis
High-dose mesalazine appears to have similar safety profile as low dose, and is not associated with greater risk of adverse events.
Asacol Data Sheet
Epidemiological data indicate that continued long-term mesalazine maintenance treatment may reduce the risk of colon cancer. Clinical efficacy and safety.
Safety and efficacy of multimatrix mesalamine in paediatric ...
We evaluated the safety and efficacy of low-dose and high-dose once-daily multimatrix mesalamine in children and adolescents with mild-to-moderate UC or those ...
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