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A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

2014-08-27 03:45:04 | BioPortfolio

Summary

The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Colitis, Ulcerative

Intervention

OPC-6535(Tetomilast)

Location

Chubu region
Japan

Status

Terminated

Source

Otsuka Pharmaceutical Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:04-0400

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Medical and Biotech [MESH] Definitions

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

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.

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.

A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.

A surgical procedure involving the excision of the COLON and RECTUM and the formation of an ILEOANAL RESERVOIR (pouch). In patients with intestinal diseases, such as ulcerative colitis, this procedure avoids the need for an OSTOMY by allowing for transanal defecation.

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