Constipation

Chronic Idiopathic Constipation (CIC)

Do you have chronic constipation?

Detailed Description:
This is a Phase 2/3, randomized, double-blind, placebo-controlled, 12-Week, study to determine the safety and efficacy of a investigational drug in patients with chronic idiopathic constipation (CIC). Subjects diagnosed with CIC who meet the inclusion and exclusion criteria for the study will enter a 2 Week pre treatment screening. During this phase patients will be required to document their bowel movements (BM diary) as they occur, and call at least once daily to complete a patient diary of questions on their symptoms (Symptom Diary) associated with CIC, as they will throughout the trial.

Inclusion Criteria includes but is not limited to:

• Male or female aged 18-75, inclusive
• Body Mass Index = 18-35 kg/m2, inclusive
• Meets criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months.
• Less than 3 Complete Spontaneous Bowel Movements per week at the start of the study and during the first 2 weeks
• Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
• Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation throughout the study.
• Willing to maintain a stable diet during the study.