Phase 3
N=276
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT02522780 ↗Enrolled (actual)
276
Serious AEs
1.8%
Results posted
Sep 2021
Primary outcome: Primary: Proportion of Subjects With Remission at Month 6 — 82; 67 Participants — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mesalamine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Remission at Month 6 |
82; 67 | >0.05 |
| SECONDARY Proportion of Subjects in Clinical Remission at Month 2, 4, and 6 |
122; 116; 113; 113; 96; 89 | >0.05 |
| SECONDARY Time to Relapse |
NA; NA | >0.05 |
| SECONDARY 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 |
14; 30 | <0.05 sig |
| SECONDARY Change From Baseline in Serum C-reactive Protein (CRP) Levels at Month 2, 4, and 6 |
0.8; 2.2; 1.0; 0.9; 0.8; 2.5 | >0.05 |
| SECONDARY Change From Baseline in Fecal Calprotectin Levels at Month 2, 4, and 6 |
-94.8; 12.8; -41.7; 53.6; -43.5; 36.4 | >0.05 |
| SECONDARY Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Scores at Months 2, 4, and 6 |
-1.3; -0.4; -0.6; -0.3; -0.5; -1.2 | >0.05 |
| SECONDARY Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
42; 49; 2; 3 | — |
| SECONDARY Severity of Adverse Events |
32; 32; 18; 22; 2; 3 | — |
| SECONDARY Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology |
0; 1; 3; 7; 2; 1 | — |
| SECONDARY Proportion of Subjects With Markedly Abnormal Laboratory Values: Coagulation |
0; 0; 0; 2; 46; 54 | — |
| SECONDARY Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry |
1; 1; 0; 0; 2; 2 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02522780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.