CLINICAL TRIALS - Heartburn
We are currently enrolling patients in a series of trials examining the treatment of heartburn. This is a brief overview of these trials.
To qualify for the trial, patients must have symptoms of gastroesophageal reflux disease (GERD) for the last three months. These symptoms include heartburn, nausea, belching, abdominal pain, difficulty swallowing, regurgitation, sour taste in the mouth and coughing. You must have heartburn specifically at least two days per week. Patients must be between the ages of 18 and 75. The investigational medication is an "extended release" version of a medication that is already on the market. The investigational medication has already completed Phase I and Phase II trials. In order to participate in this trial, ask your physician to review with you the informed consent form. There are actually a total of four trials all looking at this same medication. Your own personal symptoms and exam determine which group you qualify for. The trial involves a series of five to six office visits, and lasts six to 10 weeks.
Visit 1: Your first visit you will meet with the doctor and review the informed consent form. If all of your questions are answered, and you feel comfortable with the trial, you sign the consent form and you are now enrolled in the trial. You then have a complete history and physical exam performed by the doctor, have an EKG and other tests performed. An upper endoscopy is scheduled as well.
Visit 2: The upper endoscopy is performed. This determines which group you will qualify for. Depending upon how your esophagus looks during this procedure, you could be assigned to one of four trials. Other patients may not qualify for any trial at all. Whether you end up qualifying for a trial or not, all study procedures, visits and medication are fully covered by the sponsor of the study. You will meet with the doctor after the procedure to review the findings and determine which trial you will begin. All qualifying patients will begin study medication at this time.
Visits 3 - 6 vary depending upon which trial you enter. Some patients will need an additional upper endoscopy, while some will not. All patients will have a series of office visits in which they will review their symptom diaries, and go over how many medication doses they have taken, how many they have missed, and overall how they are feeling. Most patients will complete the trial after four weeks of treatment, while some will have eight weeks of treatment.
If you think you might qualify for these trials or are interested in learning more, contact your doctor, or you can call Dr. James Izanec at 856-547-1212 or Heather Pierce, CCRC at 856-938-4592.
