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Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis

NCT02522780•Ferring Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

Exclusion Criteria

•Evidence of other forms of inflammatory bowel disease
•Infectious disease (including human immunodeficiency virus \[HIV\], hepatitis B virus \[HBV\], or hepatitis C virus \[HCV\])
•Disease limited to proctitis \<15 cm
•Short bowel syndrome
•Prior colon resection surgery
•History of severe/fulminant UC
•Intolerant or allergic to aspirin or salicylate derivatives
•Use of rectal formulations (5-aminosalicylic acid \[5-ASA\], steroids) within ≤7 days
•Women who are pregnant or nursing
•History of known malignancy
+1 more criteria

Locations (96)

Preferred Research Partners

Little Rock, Arkansas, United States

United Research Institute

Murrieta, California, United States

Research Associates of South Florida, LLC

Miami, Florida, United States

IMIC

Palmetto Bay, Florida, United States

Medical Research Center of Florida

Pembroke Pines, Florida, United States

Lenus Research and Medical Group

Sweetwater, Florida, United States

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, United States

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Wilmington Gastroenterology Associates

Wilmington, North Carolina, United States

Associates in Gastroenterology, PLC

Hermitage, Tennessee, United States

Key Dates

Start Date

February 1, 2016

Primary Completion Date

September 19, 2018

Completion Date

September 19, 2018

Last Updated

November 8, 2021

Enrollment

276

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

Mesalamine

DRUG

Placebo

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

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RECRUITINGPHASE2

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

NCT06975722

Ulcerative Colitis

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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: November 8, 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

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in 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