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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT02522780
• Date of registration: 12/08/2015
• Prospective Registration: Yes
• Primary sponsor: Ferring Pharmaceuticals
• Public title: Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
• Scientific title: 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
• Date of first enrolment: February 1, 2016
• Target sample size: 276
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02522780
• 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, 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



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 at Month 6 [Time Frame: Month 6]

Secondary Outcome(s)

Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to Month 6]

Proportion of Subjects With an Increase From Baseline in the Clinical and Endoscopic Response Score by 2 or More Points in at Least 1 Component or by 1 or More Points in at Least 2 Components at Month 6 [Time Frame: Month 6]

Severity of Adverse Events [Time Frame: Up to Month 6]

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Scores at Months 2, 4, and 6 [Time Frame: Baseline, Month 2, 4, and 6]

Change From Baseline in Fecal Calprotectin Levels at Month 2, 4, and 6 [Time Frame: Baseline, Month 2, 4, and 6]

Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry [Time Frame: Baseline, Month 6]

Change From Baseline in Serum C-reactive Protein (CRP) Levels at Month 2, 4, and 6 [Time Frame: Baseline, Month 2, 4, and 6]

Proportion of Subjects With Markedly Abnormal Laboratory Values: Coagulation [Time Frame: Baseline, Month 6]

Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology [Time Frame: Baseline, Month 6]

Time to Relapse [Time Frame: Time from randomization to the day of withdrawal due to escalation of therapy (up to 6 months)]

Proportion of Subjects in Clinical Remission at Month 2, 4, and 6 [Time Frame: Month 2, 4, and 6]

Secondary ID(s)

000175

2015-002558-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/09/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02522780