ATTENTION SUFFERERS OF IRRITABLE BOWEL SYNDROME WITH CONSTIPATION

Study Summary: To determine the effectiveness and safety of one dose of the investigational study drug relative to placebo (an inactive substance) in individuals who have irritable bowel syndrome with constipation.

Investigational Study Drug: Linaclotide is an oral medication composed of naturally ocurring amino acids. It acts by mimicking two types of peptide hormones that the body produces in order to enhance the activity of a key regulator of intestinal function, resulting in an increase in intestinal fluid secretion and a quickening of the amount of time it takes for waste products to move through the gastrointestinal system.

STUDY INFORMATION:

• Adults at least 18 years old

• Study visits: There are 9 study visits, including a pre-screen visit.

• Study treatment regimens: There will be 1 dose of linaclotide, the investigational study drug (300 micrograms) or placebo (an inactive substance). The two regimens will be assigned randomly (like flipping a coin) in a ratio of 1:1.

• Study procedures include study-related physical exams, ECG's, and routine lab tests; a colonoscoopy will be performed at the beginning of the study for volunteers who may require it.

• There is no charge for participation (study procedures, study medication, etc. are no-cost).

• Compensation will be provided to participants to help cover study-related time and/or travel in the amount of $35 for each study visit completed (except a pre-screen visit) for a total possible of $315. Those who undergo a colonoscopy will receive an extra $50 for that visit.

• Principal Investigator: John Goff, M.D. of Rocky Mountain Gastroenterology Associates, P.C.

• Contact for information: Jodi Frazier, Study Coordinator, at 303-940-9773 (This is a message line; your call will be returned within 24 hours M-F) or jodi@wscrinc.com.

SOME OF THE INCLUSION CRITERIA FOR THIS STUDY ARE AS FOLLOWS:

INCLUSION CRITERIA (Partial List)

• At least 18 years old

• If female and able to have children, must be willing to practice birth control during the study, using one of the following methods: abstinence, hormonal contraception, double-barrier contraception (examples are condom plus IUD or diaphragm plus spermicide), or maintenance of a relationship with one male who has been surgically sterilized by vasectomy.

• Must have the following signs & symptoms of IBS with constipation:
  • Abdominal discomfort or pain associated with two or more of the following three features that must be present for at least 12 weeks (which need not be consecutive) in the past 12 months, or before starting chronic treatment with tegaserod or lubiprostone:
    • Relieved with defecation
    • Onset associated with a change in frequency of stool
    • Onset associated with a change in form (appearance) of stool
  • Less than 3 SBM's per week (an SBM is a bowel movement that occurs in the absence of the use of a laxative, enema or suppository either on the calendar day of the BM or the calendar day before the BM) associated with one or more of the following symptoms that must be present for at least 12 weeks (which need not be consecutive) in the past 12 months or before starting chronic treatment with tegaserod, lubiprostone, polyethylene glycol 3350, or any laxative:
    • Straining during more than 25% of BM'S
    • Lumpy or hard stools during more than 25% of BM's
    • Sensation of incomplete evacuation during more than 25% of BM's
• Must be willing to discontinue the use of any laxative currently being taken, after signing the informed consent document and talking with the study doctor, and take instead the rescue medication provided for this study (bisacodyl tablets or bisacodyl suppositories)
• Must have unrestricted access to a working touch-tone telephone for the entire study, and be willing to respond to daily questions regarding your chronic constipation by means of a telephone interactive voice response system
• Must be willing to refrain from making any major lifestyle changes that may affect your IBS w/constipation symptoms (such as starting a new diet or changing current exercise patterns) from the time of signing the consent for this study until the last study visit

More entry criteria will be assessed at study visits.

EXCLUSION CRITERIA (Partial List)

• Females who are pregnant or breastfeeding may not participate

• May not have had cancer within the past 5 years, except for basal cell or squamous cell skin cancer

• May not have a history of diabetic neuropathy

• May not have had one of the following types of surgery:

  • Bariatric surgery for treatment of obesity
  • Surgery to remove a segment of the stomach or intestinal tract
  • Surgery of the abdomen, pelvis, or structures lining the abdomen during the past 6 months
  • An appendectomy or cholecystectomy (gallbladder removal) during the past 60 days
  • Other major surgery in the past 30 days
  • Study participants must not experience difficulty swallowing pills.

More entry criteria will be assessed at study visits.

PLEASE CALL OR E-MAIL OUR RESEARCH OFFICE IF YOU HAVE ANY QUESTIONS, OR FOR FURTHER INFORMATION ABOUT THIS STUDY!

CONTACT INFORMATION:

Jodi Frazier, Study Coordinator

Western States Clinical Research, Inc., 9201 W. 44th Avenue, Wheat Ridge, CO 80033

Phone: 303-940-0909 (This is a message line; we will return your call within 24 hours.), FAX: 303-940-0308

E-mail: jodi@wscrinc.com

For general information about participating in clinical research studies, please see www.medhero.org or the "Being a Research Volunteer" page on this web site.

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To find out about the studies that are currently underway at our office, please see Clinical Trials.

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