Re: Female Volunteers needed for a Irritable Bowel Syndrome (IBS) Research Study

Dear Volunteer,

I am writing to inform you about a clinical research study I am currently conducting at Coastal Carolina Research Center, to evaluate an investigational medication for irritable bowel syndrome, otherwise known as IBS. This disorder, surprisingly, affects up to one in five Americans, making it one of the most common disorders diagnosed by doctors. IBS is a disorder of the intestines that can lead to abdominal pain, bloating and changes in bowel habits. It is typically characterized with either diarrhea or constipation and sometimes a person may alternate between the two conditions.

To be considered for participation in this research study, you must be a female between the ages of 18 to 65 years old, have IBS, and meet additional entry criteria for the study. If you are eligible and decide to participate, you must be willing to attend 6 office visits over approximately 19 weeks. Participation in this research study includes, at no cost:

• Regularly scheduled appointments including study-related exams
• Colonoscopy (if needed)
• Monitoring and study-related care – including lab tests and electrocardiograms (ECGs), which is a test that measures the electrical activity of the heart.
• Investigational Study Medication
• Compensation of $40 per visit ($100 for the colonoscopy if needed) for time and travel expenses.

If you are interested, know someone who may be interested in this study, or have general questions about clinical research, please contact the Coastal Carolina Research Center at 843/856-3784 or via email at ccrc@coastalcarolinaresearch.com. To respect your interest and commitment in volunteering for a clinical research study, we offer flexible appointment scheduling and are happy to answer any of your questions or concerns. We look forward to hearing from you.

Sincerely,

Cynthia B. Strout, MD
Medical Director

Coastal Carolina Research Center is a proud supporter of CISCRP, a non-profit organization focused on educating and informing the public about clinical research participation. CISCRP is not involved in recruiting patients for clinical trials nor is it involved in conducting clinical trials. For more information go to www.ciscrp.org.

Female Volunteers needed for Irritable Bowel Syndrome (IBS) clinical trial

To qualify you must:

• Be Female and between the ages of 18 and 65
• Have been diagnosed with IBS
• Diarrhea-predominant or alternating diarrhea and constipation

Duration: Up to 6 visits up to 19 weeks

Qualified participants will receive all the following at no cost:

• Study Related:
  • Regularly scheduled appointments
  • Physical Exams
  • Investigational study medication
  • Colonoscopy (if needed)
  • Electrocardiograms (ECGs) – test that measures the electrical activity of the heart

Monetary Reimbursement of $40 per visit (if needed $100 for the colonoscopy) will be provided for time and travel expenses

Please note that all persons who respond to the study via the internet will be contacted by telephone and may be entered into our patient database. All information provided by the subject during the course of this study will be treated confidentially and will adhere to any applicable federal, state or local regulations

Contact:

Coastal Carolina Research Center
1156 Bowman Rd. Ste. 102
Mount Pleasant, SC 29464
Telephone: 843-856-3784
Fax: 843-856-3788
Email: ccrc@coastalcarolinaresearch.com