UCLA researchers are seeking women between the ages of 18 and 65 with irritable bowel syndrome (IBS) for a study involving an experimental drug being developed for the condition.
"Currently there are very few medications to treat irritable bowel syndrome, a condition affecting thousands nationwide, and predominantly women," said Dr. Kirsten Tillisch, an assistant clinical professor of digestive diseases with the Center for Neurovisceral Sciences and Women's Health at the David Geffen School of Medicine at UCLA. "We are always seeking new and more effective ways to treat irritable bowel syndrome, since it can truly affect one's quality of life."
According to Tillisch, the experimental drug, called AV608, is one of a new class of drugs believed to decrease abnormal pain sensations originating from the gut. Researchers believe that the drug's actions may occur in the processing centers of pain (the spinal cord and brain) and emotions (the brain). Brain scans will be taken while participants are both on and off the experimental drug to investigate the effects.
The study will last 12 weeks, and participating women will be seen regularly by a team of physicians and nurses specializing in IBS at the Center for Neurovisceral Sciences and Women's Health. To participate in the study, women cannot be pregnant. Certain medications may not be used during enrollment in the study.
Volunteers will visit the clinic six times. Some visits will include a physical exam, blood and urine samples, and questionnaires. During three visits, volunteers will undergo testing to measure rectal sensitivity during a brain scan, which may help determine the effects of AV608.
After an initial screening visit, participants will be chosen at random to receive either a daily oral dose of AV608 or a placebo. During the second half of the study, volunteers who initially received the placebo will take the experimental drug and those who received the experimental drug will receive the placebo.
Potential side effects of AV608 include dizziness, fatigue, headache, nausea, sleepiness and inflammation of the nose and throat. The study is funded by Avera Pharmaceuticals Inc., the manufacturer of AV608.
Volunteers will receive up to $1,050 for study participation. For more information, please call Suzanne Smith at (310) 478-3711, ext. 44977.
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