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The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
Full description
The study is a prospective, randomized, multicenter, adaptive design, double blinded clinical study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.
Two arms will be assessed (at a ratio of 1:1 of Vibrant Treatment vs. placebo):
During the entire study period subjects will be asked to refrain from taking any medications or supplements to relieve their constipation.
Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement
Enrollment
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Inclusion criteria
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 inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
Clinical evidence of current and significant gastroparesis
Use of any of the following medications:
Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease.
Presence of cardiac pacemaker, gastric electrical stimulator or any electrical implanted device.
History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically significant rectocele, history of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect capsule's transit
History of Zenker's diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis or achalasia
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study
Subjects with pelvic floor dysfunction/defecatory disorder, based on subject history
Participation in another interventional clinical study within one month prior to screening.
Women who are pregnant or lactating
Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules
Inability to use an electronic daily Diary (on a computer, phone application, tablet or other electronic device) to report bowel movements, symptoms and medication usage
Subject participated in a previous Vibrant study
Subjects planning to undergo MRI during the study
Any known allergy to soybean, beeswax, Calcium Carbonate, Gelatin, Glycerin or Titanium dioxide
Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups, including a placebo group
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Central trial contact
Dvora Darky
Data sourced from clinicaltrials.gov
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