Ease of Use, Tolerability, Efficacy and Safety of the Vibrant Capsule Administered in the Home Environment

NCT02895516 | Withdrawn Phase 2

• 1 other identifier: 230CLD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective, open-label, single-arm study, to evaluate the ease of use, tolerability, efficacy and safety of the Vibrant Capsule administered in the home environment. One arm will be assessed: Vibrant Capsule administered twice a week. Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks. During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation. After 14 days the patients will return and eligibility will be re-assessed. Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Spontaneous Bowel Movements success rate

  8 weeks

Study Arms (1)

Vibrating Capsule

OTHER

Patients will receive vibrating capsule for 6 weeks of treatment (2 capsules per week)

Device: Vibrating capsule

Interventions

Vibrating capsule DEVICE

Patients will receive vibrating capsule for 6 weeks of treatment (2 capsules per week)

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 \[i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)\]; 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 (1)

University of Utah HealthCare

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

• Ashok Tuteja, MD

  University of Utah Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 9, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)