Upstate News

May 3, 2004
Doretta Royer 315 464-4833

SUNY Upstate clinical trial studies irritable bowel treatments

SYRACUSE, N.Y. — SUNY Upstate Medical University is one of 200 sites nationwide participating in a study whose findings may result in effective relief for women who suffer from diarrhea predominant irritable bowel syndrome (d-IBS). The study is sponsored by GlaxoSmithKline, Inc.

Women who are 18 years of age or older, have had severe d-IBS symptoms for at least six months, had anatomical or biochemical abnormalities of the gastrointestinal tract excluded, and have failed to respond to conventional therapy and meet all other inclusion/exclusion criteria are being sought to participate in the study. Volunteers will be reimbursed for parking fees and travel expenses. There is no charge for the medicine or for a colon procedure.

According to Philip Holtzapple, M.D., professor of medicine and pediatrics at SUNY Upstate, who is heading the study, the randomized, double-blinded and placebo-controlled study will test the safety of different doses of alosetron, (brand name Lotronex), used to treat women with severe d-IBS whose symptoms include frequent episodes of diarrhea, severe pain/discomfort, and frequent bowel urgency. “Our study will determine if a lower dose of the medication could be tolerated and used to treat a more global d-IBS population to improve their quality of life,” said Holtzapple.

The alosetron 1 mg bid dose was originally approved in the United States in February 2000 for treatment of women with d-IBS, but was withdrawn from the market later that year because of reports of serious gastrointestinal (GI) adverse events, including ischemic colitis and serious complications of constipation.

It was re-approved in June of 2002, but restricted for use only in women with severe d-IBS who experience chronic IBS symptoms, have had anatomical or biochemical abnormalities of the GI tract excluded, and who have failed to respond to conventional therapy.

A minimum of six women will be enrolled in the study locally and 1,200 nationally. Volunteers will commit a maximum of 19 weeks to this study that involves telephone entry surveys and five visits to SUNY Upstate’s Clinical Research Center, located in the Institute for Human Performance, 505 Irving Avenue, Syracuse.

Phase one of the study includes a screening period to gather baseline information such as IBS pain and discomfort levels, lower GI symptoms and disability due to IBS. It is followed by a procedure window of seven days to accommodate a colon procedure if necessary. Beginning with screening and throughout the study, volunteers will record via a telephone entry system daily self assessments of pain and discomfort severity, disability due to IBS, diarrhea and lower GI symptoms.

Volunteers who are deemed eligible during screening are then randomized into a 12-week regimen of either placebo twice a day, 0.5 mg of alosetron once a day, 1 mg. of alosetron once a day or 1 mg of alosetron twice a day. The treatment phase is followed by four weeks of observation and information gathering. During the treatment and follow-up phases, volunteers will record via a telephone entry system daily self assessments of their symptoms, weekly self-assessment of adequate relief or IBS pain and discomfort and daily lower GI symptoms, and monthly self rating of IBS global improvement.

Volunteers will also have the option to participate in pharmacogenetic research where an additional blood sample will be collected to help to identify genetic markers that might be predictive of ischemic colitis and to investigate the relationship between genetic markers and the absorption, metabolism, distribution and excretion of alosetron. The results of this study will be pooled with data from previous alosetron studies.

To learn more about the study, call 1-800-464-8668.

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