Phase 3
N=228
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT02522767 ↗Enrolled (actual)
228
Serious AEs
0.8%
Results posted
Mar 2021
Primary outcome: Primary: Proportion of Subjects With Remission — 19; 13 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
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Remission |
19; 13 | >0.05 |
| SECONDARY Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score) |
19; 11 | — |
| SECONDARY Time to Cessation of Rectal Bleeding |
18.0; 43.0 | — |
| SECONDARY The Proportion of Subjects With Endoscopic Improvement |
34; 22 | >0.05 |
| SECONDARY The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8 |
19; 17; 29; 26; 40; 28 | >0.05 |
| SECONDARY Time to Normal Stool Pattern |
55.0; NA | >0.05 |
| SECONDARY The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8 |
-0.39; -0.23; -0.56; -0.34; -0.64; -0.35 | <0.05 sig |
| SECONDARY The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8 |
0.60; 0.25; -0.86; -1.05; -2.01; -0.73 | >0.05 |
| SECONDARY The Change From Baseline in Fecal Calprotectin Levels at Week 8 |
-144.93; -119.56 | <0.05 sig |
| SECONDARY The Change From Baseline in Health Related Quality of Life (QoL) Scores |
24.79; 18.75; 33.58; 28.13; 34.41; 24.73 | <0.05 sig |
| SECONDARY Number of Participants Experiencing Adverse Events |
28; 37; 31; 1; 0; 2 | — |
| SECONDARY Severity of Adverse Events |
23; 27; 21; 6; 15; 11 | — |
| SECONDARY Proportion of Subject With Abnormal Laboratory Values (Hematology) |
0; 2; 4; 2; 4; 4 | — |
| SECONDARY Proportion of Subjects With Abnormal Laboratory Values (Coagulation) |
0; 0; 1; 14; 14; 28 | — |
| SECONDARY Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry) |
1; 0; 2; 1; 0; 2 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02522767). 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.