Constipation: Study 1
Volunteers needed, experiencing Irritable Bowel Syndrome (IBS) with constipation to participate in a research study.
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.
