Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation

Inclusion criteria

• . Subjects aged 22 years and older
• . Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives used for at least one month at recommended dose)
• . Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week
• . Normal colonoscopy performed within 5 years prior to study participation, unless the subjects are \<50 years old and without alarm signs and/or symptoms
• . Subject signed the Informed Consent Form (ICF)
• . Female subjects must have a negative blood pregnancy test during screening, confirmed by a negative urine pregnancy test during baseline and must not be lactating prior to receiving study medication. For females of child-bearing potential, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. All other female subjects must have the reason for their inability to bear children documented in the medical record \[i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)\]; in these circumstances, a pregnancy test will not be necessary