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

NCT02522780

000175

2015-002558-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 276 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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
• 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

---

276 participants in 2 patient groups, including a placebo group

Mesalamine

Experimental group

Description:

Mesalamine 2 g extended release granules (sachet), administered orally once daily (QD) for 6 months.

Treatment:

Drug: Mesalamine

Placebo

Placebo Comparator group

Description:

Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.

Treatment:

Drug: Placebo