The Patient Studies Department of Digestive Health Specialists participates in selected patient clinical trials. The trials may offer newly developed or innovative patient treatments or evaluations at no cost to patients.

We are currently evaluating patients with moderate-severe Crohn's Disease, who have not previously received treatment with "biologics" such as Remicade® (infliximab) or "immunomodulators" such as Imuran/Azathioprine. The objective of the 30 week trial is to compare to efficacy, mucosal healing and steroid sparing ability of the treatment groups during their first exposure to these two classes of medications. Following a thorough evaluation, patients will receive treatment with standard doses of Remicade, Imuran or a combination of Remicade and Imuran. Patients who complete the initial 30-week treatment period may continue to receive the study medications for an additional 24 weeks. These medications are provided at no cost by the study sponsor. A patient stipend is available to offset time and travel.

In November 2005 we will begin evaluating patients who have a history of heartburn greater than 6 months and have heartburn symptoms at least 4 days per week. During screening, patients will undergo a thorough evaluation that includes an EGD (esophogastroduodenoscopy). Patients with erosive or non-erosive changes of the esophagus and meet other enrollment requirements will qualify for treatment. The objective of the study is to compare the relief of daytime and night heartburn symptoms as recorded in an electronic diary. Following the initial 4-8 weeks treatment, patients may continue to receive medications for 6-12 months. The study is comparing Prevacid/Lansoprazole to a similar medication of the same class for erosive esophagitis and Prevacid/Lansoprazole to a similar medication of the same class and placebo for patients with non-erosive esophagitis.

If you are interested in learning more about any of our programs, please contact Patient Studies at (253) 503-2547. Please leave your name, a convenient time to contact you and your phone number. Your call will be returned promptly.

Pete Jacques, PA-C
Patient Clinical Studies Director