Phase
Condition
Constipation
Treatment
Vibrant capsule
Sham capsule
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects aged 22 years and older
Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteriaand who have not experienced relief of their symptoms from available therapies
Subjects with an average of <3 Spontaneous Bowel Movements (SBM) per week and ≥1 SBMper week
Normal colonoscopy performed within 10 years prior to study participation, unlessthe 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 pregnancy test
Exclusion
Exclusion Criteria:
History of complicated/obstructive diverticular disease
History of intestinal or colonic obstruction, or suspected intestinal obstruction.
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)
History of gastroparesis
Use of any of the following medications:
Medications that may affect intestinal motility, prokinetics, anti-depressants,anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers,aluminum/magnesium hydroxide
With the exception of antidepressants, thyroid or hormonal replacement therapy,when the subject has been on a stable dose for at least 3 months prior toenrollment.
Clinical evidence of significant respiratory, cardiovascular, renal, hepatic,biliary, endocrine, psychiatric or neurologic disease.
Presence of cardiac pacemaker or gastric electrical stimulator.
History of, or current eating disorders, such as anorexia, bulimia, or compulsoryovereating.
Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinicallysignificant rectocele, history of intestinal resection (with an exception forappendectomy, cholecystectomy and inguinal hernia repair), history of bariatricsurgery or evidence of any structural abnormality of the gastrointestinal tract thatmight affect transit
History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophagealstricture or achalasia
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
Subjects with pelvic floor dysfunction/defecatory disorder
Participation in another clinical study within one month prior to screening.
Women who are pregnant or lactating
Study Design
Study Description
Connect with a study center
Avant Guntersville
Guntersville, Alabama 35976
United StatesSite Not Available
Floridian Research Institute
Miami, Florida 33145
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.