OPDC's professionals are responsible for the clinical development of several compounds. In the gastrointestinal therapeutic area, OPDC is engaged in clinical testing of compounds intended for the treatment of ulcerative colitis.

Ulcerative colitis is a chronic (ongoing) disease of the colon, or large intestine. The disease is marked by inflammation and ulceration of the colon, mucosa, or inner most lining. Tiny open sores, or ulcers, form on the surface of the lining where they bleed and produce pus and mucus. Because the inflammation makes the colon empty frequently, symptoms typically include diarrhea (sometimes bloody) and often crampy abdominal pain.

The inflammation usually begins in the rectum and lower colon, but it may also involve the entire colon. When ulcerative colitis affects only the lowest part of the colon -- the rectum -- it is called ulcerative proctitis. If the disease affects only the left side of the colon, it is called limited or distal colitis. If it involves the entire colon, it is termed pancolitis.

Ulcerative colitis differs from another inflammatory bowel disease (IBD), Crohn's disease. Crohn's can affect any area of the gastrointestinal (GI) tract, including the small intestine and colon. Ulcerative colitis, on the other hand, affects only the colon. The inflammation involves the entire rectum and extends up the colon in a continuous manner. There are no areas of normal intestine between the areas of diseased intestine. In contrast, such so-called "skip" areas may occur in Crohn's disease. Ulcerative colitis affects only the innermost lining of the colon, whereas Crohn's disease can affect the entire thickness of the bowel wall.

Both illnesses do have one strong feature in common. They are marked by an abnormal response by the body's immune system. The immune system is composed of various cells and proteins. Normally, these protect the body from infection. In people with IBD, however, the immune system reacts inappropriately. Mistaking food, bacteria, and other materials in the intestine for foreign or invading substances, it launches an attack. In the process, the body sends white blood cells into the lining of the intestines, where they produce chronic inflammation. These cells then generate harmful products that ultimately lead to ulcerations and bowel injury. When this happens, the patient experiences the symptoms of IBD.

Neither ulcerative colitis nor Crohn's disease should be confused with irritable bowel syndrome (IBS), a disorder that affects the motility (muscle contractions) of the colon. Sometimes called "spastic colon" or "nervous colitis," IBS is not characterized by intestinal inflammation. It is, therefore, a much less serious disease than ulcerative colitis. IBS bears no direct relationship to either ulcerative colitis or Crohn's disease.

What Are the Symptons of Ulcerative Colitis?

The first symptom of ulcerative colitis is a progressive loosening of the stool. The stool is generally bloody and may be associated with crampy abdominal pain and severe urgency to have a bowel movement. The diarrhea may begin slowly or quite suddenly. Loss of appetite and subsequent weight loss are common, as is fatigue. In cases of severe bleeding, anemia may also occur. In addition, there may be skin lesions, joint pain, eye inflammation, and liver disorders. Children with ulcerative colitis may fail to develop or grow properly.

Approximately half of all patients with ulcerative colitis have relatively mild symptoms. However, others may suffer from severe abdominal cramping, bloody diarrhea, nausea, and fever. The symptoms of ulcerative colitis do tend to come and go, with fairly long periods in between flare-ups in which patients may experience no distress at all. These periods of remission can span months or even years, although symptoms do eventually return. The unpredictable course of ulcerative colitis may make it difficult for physicians to evaluate whether a particular course of treatment has been effective or not.

Source: Crohn's & Colitis Foundation of America www.ccfa.org

To learn more about clinical trials being conducted by Otsuka, please visit the U.S. National Institute of Health clinical trials registry website, www.clinicaltrials.gov.