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

NCT02030756 | Completed

• 1 other identifier: Vibrant-14-MS-CTIL
• Study Type: interventional
• Target: 144
• Locations: 2 countries
• Sites: 18

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

Conditions

Chronic Idiopathic Constipation

Keywords

constipation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vibrating capsule

ACTIVE COMPARATOR

patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].

Device: vibrating capsule

sham non-vibrating capsule

SHAM COMPARATOR

patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].

Device: sham non-vibrating capsule

Interventions

vibrating capsule DEVICE

patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].

Vibrating capsule

sham non-vibrating capsule DEVICE

patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].

sham non-vibrating capsule

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Vibrant Ltd.: lead

Study Sites (18)

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

MGG Group Co., Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Mgh Boston

Boston, Massachusetts, 02114, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Albuquerque Neuroscience

Albuquerque, New Mexico, 87109, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

CTRS LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

Huoston Methodist Hosptial

Houston, Texas, 77030, United States

Location

Bat-Yamon

Bat Yam, Israel

Location

Degani center Clalit MC

Hadera, Israel

Location

Expert clinic Clalit MC

Herzliya, Israel

Location

Talpiot clinic Clalit MC

Jerusalem, Israel

Location

Zvoulon MC Clalit MC

Kiryat Bialik, Israel

Location

100 Tower

Tel Aviv, Israel

Location

Souraski Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 8, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

US (11); IL (7)