Clinical trial NCT02030756: Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals
Official title: Assessment of the Performance, Efficacy and Safety of Vibrating Capsule Medical Device in Aiding Reliving Constipated Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Idiopathic Constipation
Keywords: constipation
Lead sponsor: Vibrant Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years and older.
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:

1. History of complicated/obstructive diverticular disease
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.

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Primary outcomes:
measure: Frequency of bowel movements
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc., Chevy Chase Clinical Research
state: Maryland
city: Boston
country: United States
facility: Mgh Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience
state: New Mexico
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: CTRS LLC
state: Pennsylvania
city: Houston
country: United States
facility: Huoston Methodist Hosptial
state: Texas
city: Bat Yam
country: Israel
facility: Bat-Yamon
city: Hadera
country: Israel
facility: Degani center Clalit MC
city: Herzliya
country: Israel
facility: Expert clinic Clalit MC
city: Jerusalem
country: Israel
facility: Talpiot clinic Clalit MC
city: Kiryat Bialik
country: Israel
facility: Zvoulon MC Clalit MC
city: Tel Aviv
country: Israel
facility: 100 Tower
city: Tel Aviv
country: Israel
facility: Souraski Medical Center
Study officials:
References: