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

Ferring Pharmaceuticals228 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

228

Conditions

Ulcerative Colitis

Interventions

MesalamineDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (93)

Outcomes

Primary Outcomes

Proportion of Subjects With Remission

The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which assessed subject's symptoms and ranged between 0-6, and Endoscopic Response which assessed objective evidence of inflammation and ranged between 0-3. Further, the Clinical Response component included two subscales: stool frequency and rectal bleeding (each ranged between 0-3 each) obtained from subjects' daily records. The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy (ranging between 0-3).

Time frame: At Week 8

Secondary Outcomes

Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)

The Modified Mayo score was calculated as the sum of the Clinical and Endoscopic Response Score (Range: 0-9, and the standard PGA score (range: 0-3; normal \[score=0\], mild disease \[score=1\], moderate disease \[score=2\], severe disease \[score=3\]). The statistical test was to be conducted only if the primary analysis was significant.

Time frame: At Week 8

Time to Cessation of Rectal Bleeding

Defined as time in days from randomization to the first day of 3 consecutive days with a rectal bleeding score of 0, based on subject's daily diary. The statistical test was to be conducted only if the primary analysis was significant.

Time frame: Up to Week 8

The Proportion of Subjects With Endoscopic Improvement

Defined as an Endoscopic Response Score of 0 or 1, with at least a 1 point reduction from baseline in the endoscopic score at Week 8.

Time frame: At Week 8

Data from ClinicalTrials.gov

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Preferred Research Partners

Little Rock, Arkansas, United States

United Research Institute

Murrieta, California, United States

Research Associates of South Florida, LLC

Miami, Florida, United States

IMIC

Palmetto Bay, Florida, United States

Medical Research Center of Florida

Pembroke Pines, Florida, United States

Lenus Research and Medical Group

Sweetwater, Florida, United States

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, United States

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Wilmington Gastroenterology Associates

Wilmington, North Carolina, United States

Associates in Gastroenterology, PLC

Hermitage, Tennessee, United States

...and 83 more locations

The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8

Defined as a score of 0 for rectal bleeding and 0 or 1 with at least 1 point decrease from baseline for stool frequency in the Clinical Response Score subset.

Time frame: At Week 2, 4, and 8

Time to Normal Stool Pattern

Defined as time in days from randomization to the first day of 3 consecutive days with a stool frequency score of 0, based on subject daily diary.

Time frame: Up to Week 8

The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8

Defined as change from baseline in rectal bleeding score at Week 2, 4, and 8 based on subject daily diary. Rectal Bleeding Score is graded 0-3, where 0 is best.

Time frame: From baseline to Week 2, 4, and 8

The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8

The adjusted mean changes in serum CRP levels from baseline and their difference between treatment groups are presented for each time point.

Time frame: From baseline to Week 2, 4, and 8

The Change From Baseline in Fecal Calprotectin Levels at Week 8

The adjusted mean change from baseline in fecal calprotectin levels at Week 8 are presented.

Time frame: From baseline to Week 8

The Change From Baseline in Health Related Quality of Life (QoL) Scores

The change from baseline to Week 2, 4, and 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) scores. The adjusted changes from baseline and their differences between treatment groups are presented. The IBDQ is an instrument used to assess quality of life in adult patients with UC. Subjects were asked to recall symptoms and QoL from last two weeks and to rate each item on a 7- point Likert score (higher scores equate to higher QoL).

Time frame: From baseline to Week 2, 4, and 8

Number of Participants Experiencing Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in a clinical trial. A 'treatment-emergent AE (TEAE)' is defined as an AE which occurs in the time interval from initial dosing (investigational medicinal product \[IMP\] intake) to the end of treatment visit. Proportion of subjects with any TEAE (serious or non-serious) are presented.

Time frame: Up to Week 16

Severity of Adverse Events

The proportion of subjects with intensity of AEs (classified as mild, moderate or severe) are presented.

Time frame: Up to Week 16

Proportion of Subject With Abnormal Laboratory Values (Hematology)

Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented. \>= greater than equal to; \<= less than equal to.

Time frame: Up to Week 16

Proportion of Subjects With Abnormal Laboratory Values (Coagulation)

Proportion of subjects with markedly abnormal changes from baseline values in coagulation laboratory values are presented. INR= International normalized ratio.

Time frame: Up to Week 16

Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry)

Proportion of subjects with markedly abnormal changes in serum chemistry laboratory values are presented. ALT= Alanine aminotransferase; AST= Aspartate aminotransferase; BUN= Blood urea nitrogen; GGT= Gamma glutamyl transferase.

Time frame: Up to Week 16