Feb 3 2016
Ulcerative Colitis (UC) is a chronic disease of the colon that causes the colon to become inflamed and forms ulcers. UC is a type of irritable bowel disease (IBD), which is a term that describes conditions with chronic or recurring inflammation of the gastrointestinal tract. The number of patients diagnosed with IBD has increased significantly across the past 50 years, with 1.6 million people in the United States alone affected by IBD. The incidence of IBDs, including UC, is highest among people between the ages of 20 and 40, often affecting individuals during their healthiest and most productive years of life.
Managing the symptoms of UC is a constant challenge for patients with frequent bathroom trips, abdominal cramps, and diarrhea significantly affecting the day-to-day routines of people with the disease. The availability of an oral medication such as the one being studied in the OASIS clinical study could offer patients an additional, more convenient treatment for UC.
The OASIS clinical study is evaluating an investigational medication to learn if it may safely and effectively reduce the inflammation of the gut in patients with moderately to severely active UC. The medication is considered investigational because it is not approved by health authorities, including the U.S. Food and Drug Administration (FDA), for the treatment of UC.
Clinical studies are done to help determine if investigational medications are safe and are effective in treating diseases and conditions. People volunteer to participate in clinical studies and these studies play an important role in the development of medications. Many drugs, therapies, and devices that are used today are the result of past clinical studies.
The study is being conducted at more than 100 clinical centers worldwide, and about 240 adults aged 18 to 80 will participate in the OASIS clinical study. The study will last about 16 to 18 weeks and include 7 to 10 visits to the study clinic.