Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration

NCT02829047 | Terminated Results

• 1 other identifier: 220CLD
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

The study is a prospective, multicenter, open-label, single-arm study, to evaluate the tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Spontaneous Bowel Movements Success Rate

  Defined as the number of subjects with an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 3 of the 6 weeks of treatment. Subjects with less than 2 weeks (with at least 5 days per week) of valid diary during the treatment period will be considered as non-evaluable.

  6 weeks of treatment

Study Arms (1)

Vibrating Capsule

OTHER

Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)

Device: Vibrating Capsule

Interventions

Vibrating Capsule DEVICE

Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)

Vibrating Capsule

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 22 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 used for at least one month at recommended dose)
• Patients with an average of less than 3 Spontaneous Bowel Movements per week and at least 1 Spontaneous Bowel Movements per week
• Normal colonoscopy performed within 10 years prior to study participation, unless the patients are less than 50 years old and without alarm signs and/or symptoms
• Patient signed the Informed Consent Form
• Female subjects must have a negative urine pregnancy test and must not be lactating prior to receiving study medication. For females of child-bearing potential, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. All other female subjects must have the reason for their inability to bear children documented in the medical record; in these circumstances, a urine pregnancy test will not be necessary.

You may not qualify if:

• History of complicated/obstructive diverticular disease
• History of intestinal or colonic obstruction, or suspected intestinal obstruction.
• History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
• History of gastroparesis
• Use of any of the following medications:
• Medications that may affect intestinal motility, prokinetics, anti-depressants, anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium hydroxide
• With the exception of antidepressants, thyroid or hormonal replacement therapy, when the subject has been on a stable dose for at least 3 months prior to enrollment.
• Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease.
• Presence of cardiac pacemaker or gastric electrical stimulator.
• History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
• Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically significant rectocele, history of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit
• History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia
• Chronic use of non-steroidal anti-inflammatory drugs: chronic use is defined as taking full dose non-steroidal anti-inflammatory drugs more than three times a week for at least six months. Patients on cardiac doses of aspirin may be enrolled in the study
• Patients with pelvic floor dysfunction/defecatory disorder, based on patient history
• Participation in another clinical study within one month prior to screening.

Sponsors & Collaborators

• Vibrant Ltd.: lead

Study Sites (4)

Avant Guntersville

Guntersville, Alabama, 35976, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Floridian Research Institute

Miami, Florida, 33145, United States

Location

Albuquerque Neuroscience

Albuquerque, New Mexico, 87109, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical trials manager
• Organization: Vibrant Gastro

service@vibrantgastro.com

046663322

Study Officials

• Eamonn Quigley, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 12, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)