Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.

Key facts

Study ID

NCT02522767

Run by

Ferring Pharmaceuticals

People needed

228

Starts

2015-10-01

Expected to finish

2018-04-03

Last updated by the study team

2021-03-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged 18 to 75 years
• Mild to moderate UC

You may not qualify if…

• Disease limited to proctitis <15 cm
• Short bowel syndrome
• Prior colon resection surgery
• History of severe/fulminant UC
• Evidence of other forms of inflammatory bowel disease
• Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
• 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 or known malignancy
• History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial

Where it is running

• 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
• Quality Medical Research, PLLC — Nashville, Tennessee, United States
• BI Research Center — Houston, Texas, United States
• Biopharma Informatic Inc. — Houston, Texas, United States
• Digestive Health Center — Pasadena, Texas, United States
• DM Clinical Research — Tomball, Texas, United States
• Advanced Research Institute — Ogden, Utah, United States
• New River Valley Research Institute — Christiansburg, Virginia, United States
• Digestive & Liver Disease Specialists — Norfolk, Virginia, United States
• Multiprofile Hospital For Active Treatment Avis Medica — Pleven, Bulgaria
• Medical Center Excelsior OOD — Sevlievo, Bulgaria
• Medical Center-1-Sevlievo EOOD — Sevlievo, Bulgaria
• City Clinic University Multiprofile Hospital for Active Treatment EOOD — Sofia, Bulgaria
• Medical Center Asklepion - Humane Medicine Research EOOD — Sofia, Bulgaria
• University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD — Sofia, Bulgaria
• University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD — Sofia, Bulgaria
• Preferred Research Partners — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.