What side effects are associated with this type of intervention?

Mesalamine, a common treatment for Ulcerative Colitis, is generally well-tolerated but can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Other 5-ASA agents, like sulfasalazine, may have additional side effects including gastrointestinal upset and allergic reactions. These medications work by inhibiting the production of inflammatory chemicals in the colon, helping to reduce inflammation and maintain remission.

What prior FDA approvals exist?

The FDA has approved several 5-aminosalicylates (5-ASA) for the treatment of Ulcerative Colitis, including Mesalamine, Sulfasalazine, Balsalazide, and Olsalazine. These drugs work by inhibiting the production of inflammatory chemicals in the colon, thereby reducing inflammation and promoting remission. Mesalamine is available in various formulations, such as oral tablets, capsules, enemas, and suppositories, to target different parts of the colon. Other related drugs include corticosteroids and immunomodulators, which are used for more severe cases or when 5-ASA drugs are not effective.

What other types of research exist?

Promising novel alternatives to Mesalamine for Ulcerative Colitis patients include biologic agents such as Infliximab, Adalimumab, and Vedolizumab, which target specific components of the immune system to reduce inflammation. Additionally, small molecules like Tofacitinib, a Janus kinase inhibitor, have shown efficacy in treating moderate to severe UC. Ustekinumab, an anti-IL 12/23 antibody, is another option for patients who have not responded to other treatments. These therapies offer targeted approaches to managing UC and may be considered based on individual patient profiles and disease severity.

← Back to Search

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

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 • NCT01412372

10%

light headed/dizziness

Increased bowel movement

Abdominal Pain

Sinusitis

Reflux

Upper respiratory infection

Fatigue

Nausea

Sharp pain

Motion Sickness

Bloating

Swelling

Weight Gain

Fever

Hematochezia

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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.