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Therapeutic Areas: Gastroenterology | Infections and Infectious Diseases | Family Medicine
Disease Category: Irritable Bowel Syndrome (IBS)
Location: United States, FL

Clinical Trial Details

Overview

Research Study Summary

Volunteers needed, experiencing Irritable Bowel Syndrome (IBS) with constipation to participate in a research study.

Purpose

23 week study comparing an oral investigational medication versus placebo (inactive substance) administered once daily in male and female subjects 18 years of age and older.

Inclusion Criteria:

  • Have access to a touch-tone phone for the duration of the study to complete daily diary calls.
  • Abdominal pain or discomfort that has 2 or more of the following for at least 12 weeks, which need not be consecutive, in the 12 months before the Screening Visit:
    • Relieved with defecation
    • Onset associated with a change in frequency of stool
    • Onset associated with a change in appearance of stool
  • Fewer than 3 bowel movements a week, without the use of laxatives, and 1 or more of the following symptoms for at least 12 weeks, which need not be consecutive, in the 12 months before Screening Visit:
    • Straining during more than 25% of bowel movements
    • Lumpy or hard stools during more than 25% of bowel movements
    • Sensation of incomplete evacuation during more than 25% of bowel movements
  • Be willing to discontinue laxative use during the study visit in favor of the study-defined rescue medication

Exclusion Criteria:

  • Report loose or watery stools for more than 25% of bowel movements during the 12 weeks prior to screening.
  • Bariatric surgery (surgery for obesity), surgery of the abdomen, pelvis or retroperitoneal structures 6 months prior to Screening. Appendectomy or cholecystectomy 60 days prior to Visit 1.
  • Gastrointestinal bleeding, iron deficient anemia, colitis, diverticulits, chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis or active peptic ulcer disease.
  • Use of narcotics, non steroidal anti-inflammatory medication for abdominal pain or discomfort, or any medication used for weight loss.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Duration

23 Weeks

Facility Type

N/A

Contact

Jessica Elkins Hochstetler RN, CCRC, Director Of Clinical Research
Emerald Coast Research Associates
221 East 23rd Street ,Suite B
Panama City, FL 32405
Phone: (850) 785-6550

View Map

Research Center Information: Emerald Coast Research Associates

CW ID: 158473

Date Last Changed: July 24, 2013


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