Loading clinical trials...

Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)

A Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC)

NCT00446849•Shire

View on ClinicalTrials.gov

Summary

To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female subjects aged at least 18 years with active mild to moderate UC may enter the Acute Phase of the study.
•2. Must have a previous diagnosis of UC confirmed by histology and endoscopy or radiology.
•3. Males or non-pregnant, non-lactating FOCP who have a negative serum pregnancy test prior to entering the study and who are using adequate forms of contraception for the duration of the study.
•4. General medical assessment must be satisfactory and there must not be clinically significant and relevant abnormalities.
•5. Subject must have had \>2 acute episodes of UC (a documented episode of increased bowel frequency with rectal blood loss for which UC therapy was intensified) in their medical history.
•6. Subjects who have relapsed on maintenance therapy after 2 weeks with doses of mesalamine at: a. \<2.0g/day, will be allowed into the Acute Phase at 2.4g/day QD, or b. between 2.0g/day - 3.0g/day will be allowed into the Acute Phase at 4.8g/day QD.
•1. Subjects determined to be quiescent at study entry on prior oral mesalamine therapy will be eligible to enter directly into the Maintenance Phase.
•2. UC must have been considered to be quiescent, with scores of zero for both rectal bleeding and bowel movements.

Exclusion Criteria

•1. Subjects who have been in relapse for \>6 weeks.
•2. Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening.
•3. Subjects must not have used another investigational agent within the last 30 days prior to enrollment.
•4. Subjects who have unsuccessfully treated their current relapse with steroids or a mesalamine dose of \>2.0 g/day.
•5. Subjects who have relapsed on maintenance therapy with doses of mesalamine \>2.0g/day. If the subject had a recent dose reduction from 2.0g/day to less than or equal to 2.0g/day and relapsed within 2 weeks of that dose reduction, the subject will not be eligible.
•6. Subjects who have used systemic or rectal steroids within the last 4 weeks prior to Baseline, immunosuppressants within the last 6 weeks, antibiotic use within the last 7 days or chronic use of any anti-inflammatory drugs within 7 days prior to Baseline.
•7. Subjects with hypersensitivity to salicylates/aspirin are excluded.
•8. Subjects with moderate or severe hepatic impairment.
•9. Subjects with Crohn's Disease, proctitis (where the extent of inflammation is less than or equal to 15cm), short bowel syndrome, bleeding disorders, or active peptic ulcer disease.
•10. Subjects with asthma are excluded only if they are known to be mesalamine-sensitive.
+8 more criteria

Locations (62)

Birmingham Gastroenterology Assoc.

Birmingham, Alabama, United States

Clopton Clinic

Jonesboro, Arkansas, United States

VA Medical Center - Long Beach

Long Beach, California, United States

Sharp Rees-Stealy Medical Group

San Diego, California, United States

Clinical Applications Laboratories, Inc.

San Diego, California, United States

South Denver Gastroenterology, P.C.

Englewood, Colorado, United States

The Center for GI Medicine of Fairfield & Westchester, P.C.

Greenwich, Connecticut, United States

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Connecticut Gastroenterology Associates

New Haven, Connecticut, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Key Dates

Start Date

May 1, 2007

Primary Completion Date

August 17, 2009

Completion Date

August 17, 2009

Last Updated

June 14, 2021

Enrollment

290

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

MMX Mesalamine

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

View study

RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

View study

RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects