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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.
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Otsuka Pharmaceutical Co., Ltd.
Published on BioPortfolio: 2014-08-27T03:45:04-0400
To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.
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 ...
This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficac...
Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S. The disease can vary in severity and multiple drug classes are available to the disease depend...
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...
Crohn's disease is a chronic inflammatory bowel disease that requires lifelong multidisciplinary management. Seventy percent of patients affected by Crohn's disease will require at least one surgical ...
Reduced intestinal microbial diversity and bacterial imbalance (dysbiosis) are seen in studies of Crohn's disease. As it is difficult to obtain biopsy samples before disease presentation, the earliest...
Ustekinumab (UST) is effective in the treatment of adults with moderate to severe Crohn's disease (CD). There is a paucity of data on its use in children.
/Aims: Treatment goals in Crohn's disease (CD) have evolved to target mucosal healing. There is now a drive to determine if non-invasive measures can adequately identify the attainment and persistence...
Presence of perianal fistulas in Crohn's disease (CD) denotes increased disease aggressiveness. We studied epidemiology and clinical outcomes of perianal CD (PCD) using Hong Kong territory-wide IBD Re...
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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Crohn's Disease (CD)
Crohn’s disease (CD) is a long-term condition that causes inflammation of the lining of the digestive system. Inflammation can affect any part of the digestive system, from the mouth to the back passage, but most commonly occurs in the last s...