Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals
NCT ID: NCT02030756
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2014-07-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vibrating capsule
patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
vibrating capsule
patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
sham non-vibrating capsule
patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
sham non-vibrating capsule
patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
Interventions
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vibrating capsule
patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
sham non-vibrating capsule
patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
Eligibility Criteria
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Inclusion Criteria
2. Patients with chronic idiopathic constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which was used for at least one month at recommended dose).
3. Patients with more than 1 bowel movement/2 weeks and \< 3 bowel movement/week.
4. Colonoscopy performed in the past 10 years prior to study participation, unless the patients are \<50 years old and without alarming signs and symptoms
5. Patient signed ICF
6. For women with childbearing potential, adequate contraception
Exclusion Criteria
2. History of intestinal or colonic obstruction.
3. History of significant GI disorder.
4. Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids
5. Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.
6. Presence of pacemaker.
7. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
8. Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality, including GI resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia.
9. History of Zenker's diverticulum, dysphagia or a known esophageal stricture 10. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
11\. Participation in another clinical study in the last 4 months prior to screening.
12\. Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study.
13\. Women who are pregnant or lactating.
\-
18 Years
80 Years
ALL
No
Sponsors
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Vibrant Ltd.
INDUSTRY
Responsible Party
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Locations
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Borland-Groover Clinic
Jacksonville, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Mgh Boston
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, United States
NYU Langone Medical Center
New York, New York, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
CTRS LLC
Pittsburgh, Pennsylvania, United States
Huoston Methodist Hosptial
Houston, Texas, United States
Bat-Yamon
Bat Yam, , Israel
Degani center Clalit MC
Hadera, , Israel
Expert clinic Clalit MC
Herzliya, , Israel
Talpiot clinic Clalit MC
Jerusalem, , Israel
Zvoulon MC Clalit MC
Kiryat Bialik, , Israel
100 Tower
Tel Aviv, , Israel
Souraski Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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Vibrant-14-MS-CTIL
Identifier Type: -
Identifier Source: org_study_id