Status:
COMPLETED
A Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes
Lead Sponsor:
Vibrant Ltd.
Conditions:
Constipation
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled pilot study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjec...
Detailed Description
Subjects will be followed continuously for at least a 2 weeks run-in period and then be randomized to either Vibrant or Sham capsules for a treatment period of 8 weeks. The first 2 weeks of treatment ...
Eligibility Criteria
Inclusion
- Subjects aged 22 years and older
- Subjects with Chronic Idiopathic Constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies
- Subjects with an average of \<3 Spontaneous Bowel Movements per week and ≥1 Spontaneous Bowel Movements per week
- Normal colonoscopy performed within 10 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
- Female subjects must have a negative pregnancy test
Exclusion
- 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
- History of gastroparesis
- Use of any of the following medications:
- Medications that may affect intestinal motility, prokinetics, 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 to enrollment.
- 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 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 transit
- History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture 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
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2018
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03329027
Start Date
November 14 2017
End Date
March 30 2018
Last Update
July 3 2024
Active Locations (4)
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1
Hope Clinical Research
Canoga Park, California, United States, 91303
2
Albuquerque Neuroscience
Albuquerque, New Mexico, United States, 87109
3
Great Lakes Medical Research
Willoughby, Ohio, United States, 44094
4
Health Research of Hampton Roads
Newport News, Virginia, United States, 23606