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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
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 Ulcerative Colitis
9 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had severe cell changes, certain infections, or treatments with biological drugs.Meets one of the following conditions:I have a documented history of ulcerative colitis or its complications.I have recently used steroids, immunosuppressants, or specific medications.I am between 18 and 64 years old.I am using birth control or have had a negative pregnancy test.My doctor says my condition is severe.I am following the required contraceptive measures.I have a history of ulcerative colitis affecting the left side of my colon, and it's currently mild to moderate.I have a history of cancer, asthma, or substance abuse.I do not have other serious illnesses that could affect my participation.My ulcerative colitis is moderately active according to my doctor's assessment.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Mesalamine Enema
- Group 2: Zoenasa-1:4
Awards:
This trial has 3 awards, including:- 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.