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A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease

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

Summary

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

Study Design

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

Conditions

Crohn Disease

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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To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients

To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.

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

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 ...

CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission

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Use of PET-CT in the Management of Crohn's Disease

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Use of FDG PET/CT to Evaluate Crohn Disease

The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn Disease and recurrence of Crohn disease after having compared results of PET/CT's with results o...

PubMed Articles [14405 Associated PubMed Articles listed on BioPortfolio]

Fibrostenotic Phenotype of Myofibroblasts in Crohn's Disease is Dependent on Tissue Stiffness and Reversed by LOX Inhibition.

Crohn's disease is a chronic inflammatory disorder of the intestine and often leads to fibrosis, characterized by excess extracellular matrix [ECM] deposition, increased tissue stiffness, and strictur...

Genomic and expression analyses identify a disease modifying variant for fibrostenotic Crohn's disease.

Crohn's Disease (CD) is a chronic inflammatory disease with unpredictable behaviour. More than half of CD patients eventually develop complications such as stenosis, for which they then require endosc...

A BACH2 Gene Variant Is Associated with Postoperative Recurrence of Crohn's Disease.

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Detection of infection mimicking Crohn's disease using video capsule endoscopy.

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An examination of appetite and disordered eating in active Crohn's disease.

Crohn's disease (CD) patients suffer from nutritional deficiencies when in active disease. We aim to examine calorific intake, macronutrient choice and disordered eating behaviour in patients with act...

Medical and Biotech [MESH] Definitions

A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.

A condition characterized by persistent or recurrent labial enlargement, ORAL ULCER, and other orofacial manifestations in the absence of identifiable CROHN DISEASE; or SARCOIDOSIS. There is no consensus on whether orofacial granulomatosis is a distinct clinical disorder or an initial presentation of Crohn disease.

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

A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.

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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