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A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis

2014-08-27 03:16:48 | BioPortfolio

Summary

The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were:

- To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and

- To evaluate the safety of MDRT 2.4 g per day (800 mg three times daily) compared to placebo.

Description

This was a multi-center, randomized, parallel-groups comparison of two mesalamine products for treatment of ulcerative colitis. Patients were randomly assigned in an optimized 2:2:1 ratio to MDRT 2.4 g/day, Asacol 2.4 g/day, or placebo. The study was partially blinded due to the difficulties associated with creating placebo that matched both MDRT and Asacol; the placebo matched the MDRT formulation. Placebo groups served as control in the parallel group comparison between MDRT and Asacol. Patients were treated for 6 weeks after randomization and followed through Day 56, which was considered of sufficient length to accommodate any safety issues and to assess efficacy based upon prior clinical trials of mesalamine in patients with mild to moderate active UC as described in the introduction

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment

Conditions

Mild to Moderate Ulcerative Colitis

Intervention

Placebo, Mesalamine, Mesalamine

Status

Completed

Source

EMET Pharmaceuticals, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:48-0400

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Medical and Biotech [MESH] Definitions

A drug that is used in the management of inflammatory bowel diseases. Its activity is generally considered to lie in its metabolic breakdown product, 5-aminosalicylic acid (see MESALAMINE) released in the colon. (From Martindale, The Extra Pharmacopoeia, 30th ed, p907)

An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed)

Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.

An acute form of MEGACOLON, severe pathological dilatation of the COLON. It is associated with clinical conditions such as ULCERATIVE COLITIS; CROHN DISEASE; AMEBIC DYSENTERY; or CLOSTRIDIUM ENTEROCOLITIS.

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