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

Ferring

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Mesalamine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02522767

000174

2015-002557-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 228 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 2 patient groups, including a placebo group

Mesalamine

Experimental group

Description:

4 g extended release granules (sachet)

Treatment:

Drug: Mesalamine

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo