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

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation

In brief

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

Key facts

Study ID

NCT02030756

Run by

Vibrant Ltd.

People needed

144

Starts

2014-07-01

Expected to finish

2016-02-01

Last updated by the study team

2017-11-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Participation in another clinical study in the last 4 months prior to screening.
• 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.
• Women who are pregnant or lactating.

Where it is running

• 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

Full record on ClinicalTrials.gov

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