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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02522767
• Date of registration: 12/08/2015
• Prospective Registration: Yes
• Primary sponsor: Ferring Pharmaceuticals
• Public title: Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis
• Date of first enrolment: October 2015
• Target sample size: 228
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02522767
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belgium, Bulgaria, Canada, Hungary, Latvia, Mexico, Poland, Russian Federation, Serbia, Switzerland, Ukraine, United States

Contacts

• Name: Global Clinical Compliance
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Mesalamine

Drug: Placebo

Primary Outcome(s)

Proportion of subjects with remission [Time Frame: At Week 8]

Secondary Outcome(s)

Incidence of adverse events [Time Frame: Up to Week 16]

Proportion of subjects with remission in the primary endpoint and the Physician's Global Assessment (PGA) [Time Frame: At Week 8]

Time to cessation of rectal bleeding [Time Frame: Up to Week 8]

Severity of adverse events [Time Frame: Up to Week 16]

Secondary ID(s)

000174

2015-002557-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors