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

Inclusion Criteria:

1. Subjects aged 22 years and older

2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteriaand who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives used for at least one month at recommended dose)

3. Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1SBM per week

4. Normal colonoscopy performed within 5 years prior to study participation, unless thesubjects are <50 years old and without alarm signs and/or symptoms

5. Subject signed the Informed Consent Form (ICF)

6. Female subjects must have a negative blood pregnancy test during screening,confirmed by a negative urine pregnancy test during baseline and must not belactating prior to receiving study medication. For females of child-bearingpotential, a hormonal (i.e., oral, implantable, or injectable) and single-barriermethod, or a double-barrier method of birth control must be used throughout thestudy. All other female subjects must have the reason for their inability to bearchildren documented in the medical record [i.e., tubal ligation, hysterectomy, orpost-menopausal (defined as a minimum of one year since the last menstrual period)];in these circumstances, a pregnancy test will not be necessary

Exclusion Criteria:

History of complicated/obstructive diverticular disease 2. History of intestinal or colonic obstruction, or suspected intestinal obstruction.

3. History of significant gastrointestinal disorder, including any form of inflammatorybowel disease or gastrointestinal malignancy (celiac disease is accepted if thesubject has been treated and is in remission) 4. History of gastroparesis 5. Use ofany of the following medications:

• Medications that may affect intestinal motility, prokinetics, anti-Parkinsonianmedications, opiates, opioids, calcium-channel blockers, aluminum/magnesiumhydroxide

• With the exception of antidepressants, thyroid or hormonal replacement therapy, whenthe subject has been on a stable dose for at least 3 months prior to enrollment.

6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic,biliary, endocrine, psychiatric or neurologic disease 7. Presence of cardiacpacemaker or gastric electrical stimulator. 8. History of, or current eatingdisorders, such as anorexia, bulimia, or compulsory overeating.

7. Diagnosis of mega-rectum or colon, congenital anorectal malformation,clinically significant rectocele, history of intestinal resection (with anexception for appendectomy, cholecystectomy and inguinal hernia repair),history of bariatric surgery or evidence of any structural abnormality of thegastrointestinal tract that might affect transit 10. History of Zenker'sdiverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia

8. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic useis defined as taking full dose NSAIDs more than three times a week for at leastsix months. Subjects on cardiac doses of aspirin may be enrolled in the study

9. Subjects with pelvic floor dysfunction/defecatory disorder, based onsubject history 13. Participation in another clinical study within one monthprior to screening.

10. Women who are pregnant or lactating 15. Use of any medication for constipationrelief during the study, except as rescue medication, as indicated by studyrules 16. Inability to use an electronic daily Diary (on a computer, phoneapplication, tablet or other electronic device) to report bowel movements,symptoms and medication usage 17. Subject participated in a previous Vibrantstudy 18. Subjects planning to undergo MRI during the study 19. Any knownallergy to soybean or beeswax or Calcium Carbonate 20. Any other conditionwhich in the opinion of the investigator may adversely affect the safety of thesubject or would limit the subject's ability to complete the study