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We have several single site clinical trials and also participate in a large number of multi-center clinical trials. The success of these trials is dependent upon recruitment of appropriate subjects. We want to update you about these trials so that you can hopefully help us recruit potential subjects.
Each trial has specific inclusion/ exclusion criteria which we will go through with each potential subject during the informed consent and screening process. All we are asking you to do is help identify potential subjects. WE WILL DO THE REST.
We have found that many subjects/ patients enjoy participating in clinical trials because they feel they are contributing to medical knowledge. Of course, in most of the trials, neither the subjects nor their insurance companies are charged for study related expenses. In fact, in some trials we have found that clinically indicated procedures or care are included in the study budget. In most of our studies, subjects are also reimbursed for their time and travel.
If you see any people that you think may qualify, please feel free to call Karen Bednar or Justin Boike! We appreciate your help!
Karen Bednar , 5-4071 pgr. (312) 556-5695
Justin Boike, 3-7676 pgr. #4288
Below are the currently active studies:
A 6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who are at Risk of Developing NSAID-associated Ulcers
This study is sponsored by the pharmaceutical company, POZEN Inc conducted by Dr. Jay Goldstein. This study examines the effectives of a combination drug that includes a PPI coated NSAID. People who are diagnosed with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or any other medical condition expected to require daily NSAID therapy for at least 6 months could qualify for any of these studies. The study duration is approximately 6 months.
Does Acetaminophen Potentiate the Gastroduodenal Mucosal Injury of Aspirin? A Prospective, Randomized, Pilot Study.
This study is sponsored by Pfizer, Inc and is conducted by Dr. Jay Goldstein We are looking for healthy volunteers. The study duration is approximately 3-4 weeks. Subjects will be randomized to 3 treatment arms, Acetaminophen + Aspirin, Acetaminophen + placebo, Aspirin + Placebo.
A Randomized, Open-Label, Comparative 3-way Crossover Study of 24-hour Intragastric pH profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients with Symptomatic GERD
This study is sponsored by AstraZeneca and conducted by Dr. Jay Goldstein. This study is being done to compare the efficacy of three PPI's in controlling stomach acid in the Hispanic population. Eligible subjects need to be diagnosed with GERD and be of Hispanic origin. Qualified subjects will be administered one of three chosen PPI's and will have a subsequent 24-hour pH probe placed to measure acid in the esophagus. Subjects will repeat this process 3 times with a washout period following each measurement. The study duration is approximately 6-8 weeks.
Evaluation of the PillCam™ESO Capsule in the Detection of Esophageal Varices
This study, conducted by Dr. Jay Goldstein, compares the use of the esophageal (ESO) PillCam to a screening or surveillance EGD in people with known or suspected esophageal varices. Any patient scheduled for a screening/surveillance EGD could qualify for this study. The study involves only one visit and is completed on the same day as the subject's EGD procedure.
A Multicenter, Randomized, Double-Blind, Actively Controlled Trial to evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 G BID Versus Mesalamine (5-ASA) as Asacol 0.8 G TID in Mildly to Moderately Active Ulcerative Colitis
This study, conducted by Dr. Allan Halline, examines the efficacy of a new twice daily dosing of Balsalazide (Colazal) in Ulcerative Colitis patients. Subjects with moderately active Ulcerative Colitis may qualify for this study.
Phase IIA Trial of Curcumin Among Patients with Prevalent Subclinical Neoplastic Lesions or Aberrant crypt foci
Dr. Richard Benya is the PI for this study which is sponsored by the Nation Cancer Institute. This study is looking at the effects of curcumin on aberrant crypt foci which are believed to be the precursor of polyp development. Any persons scheduled for a screening colonoscopy may choose to have a magnification colonoscopy and potentially qualify for the study. The study duration is approximately 30 days.
Randomized, Phase II Trial of Atorvastatin, RAFTILOSE Synergy1 and Sulindac Among Patients at Increased Risk for Sporadic Colorectal Neoplasia
Dr. Richard Benya is also the PI for this study which is sponsored by the Mayo Clinic and the Cancer Prevention Network. This study looks at the effects of several study drugs on aberrant crypt foci in people who have been found to have a dysplastic polyp or a history of colon cancer. The approximate duration of this study is 6 months.
If you are interested in participating, or know of people who may qualify, please call Karen Bednar, RN, APN at 312-355-4071 or Justin Boike at (312) 413-7676.
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