← Back to Search

5-ASA Derivative

Zoenasa vs Mesalamine Enema for Ulcerative Colitis

Phase 2
Waitlist Available
Research Sponsored by Altheus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects aged between 18 and 64 years
Male subjects must meet specific contraceptive requirements
Must not have
Documented history of specific types of ulcerative colitis or related complications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is designed to study the safety and efficacy of Zoenasa Rectal Gel, compared to mesalamine enema, in subjects with left-sided ulcerative colitis.

Who is the study for?
Adults aged 18-64 with left-sided ulcerative colitis and mild to moderate disease activity can join. They must have stable liver function tests, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with severe diseases, recent mesalamine or steroid use, history of certain cancers or drug abuse, allergy to trial drugs, or inability to retain enemas.
What is being tested?
The study compares Zoenasa Rectal Gel (a combination of N-acetylcysteine and mesalamine) against a standard mesalamine enema in treating left-sided ulcerative colitis over six weeks. Participants will be randomly assigned to one of the two treatments in equal numbers for comparison.
What are the potential side effects?
Potential side effects may include digestive discomfort due to the rectal administration of medication and possible allergic reactions if sensitive to ingredients like N-acetylcysteine or mesalamine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 64 years old.
Select...
I am following the required contraceptive measures.
Select...
I have a history of ulcerative colitis affecting the left side of my colon, and it's currently mild to moderate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a documented history of ulcerative colitis or its complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in modified UCDAI at 6 weeks
Secondary study objectives
Change in modified UCDAI at 3 weeks
Clinical and endoscopic remission rates at 3 weeks
Clinical and endoscopic remission rates at 6 weeks

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Zoenasa-1:4Experimental Treatment1 Intervention
Group II: Mesalamine EnemaActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Altheus Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Colitis
9 Patients Enrolled for Colitis

Media Library

Mesalamine Enema (5-ASA Derivative) Clinical Trial Eligibility Overview. Trial Name: NCT01586533 — Phase 2
Mesalamine Enema (5-ASA Derivative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01586533 — Phase 2
Colitis Research Study Groups: Mesalamine Enema, Zoenasa-1:4
Colitis Clinical Trial 2023: Mesalamine Enema Highlights & Side Effects. Trial Name: NCT01586533 — Phase 2
~9 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top