Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals

Study Overview
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Brief Summary
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This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals

Official Title
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Assessment of the Performance, Efficacy and Safety of Vibrating Capsule Medical Device in Aiding Reliving Constipated Individuals.

Conditions
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Chronic Idiopathic Constipation

Intervention / Treatment
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* Device: vibrating capsule
* Device: sham non-vibrating capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years and older. 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). Patients with more than 1 bowel movement/2 weeks and < 3 bowel movement/week. Colonoscopy performed in the past 10 years prior to study participation, unless the patients are <50 years old and without alarming signs and symptoms Patient signed ICF For women with childbearing potential, adequate contraception Exclusion Criteria: History of complicated/obstructive diverticular disease History of intestinal or colonic obstruction. History of significant GI disorder. 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 Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers. Presence of pacemaker. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating. 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. 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vibrating capsule<br>patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. | Device: vibrating capsule<br>* patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].<br>|
| Sham Comparator: sham non-vibrating capsule<br>patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. | Device: sham non-vibrating capsule<br>* patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of bowel movements | change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation