A Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes

A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes

The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled pilot study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.

Three arms will be assessed:

• Vibrant Capsule with vibrating mode 1 administered 5 times per week
• Vibrant Capsule with vibrating mode 2 administered 5 times per week
• Sham Capsule administered 5 times per week

Subjects will be followed continuously for at least a 2 weeks run-in period and then be randomized to either Vibrant or Sham capsules for a treatment period of 8 weeks. The first 2 weeks of treatment will be considered as a subjects' training period.

Data reporting will be done on an electronic Case Report Form and an eDiary. Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period.

After the run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit.

Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period.

Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Device: Vibrating Capsule; Device: Sham capsule

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience
  • Ohio
    • Willoughby, Ohio, United States, 44094
      • Great Lakes Medical Research
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects aged 22 years and older
• Subjects with Chronic Idiopathic Constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies
• Subjects with an average of <3 Spontaneous Bowel Movements per week and ≥1 Spontaneous Bowel Movements per week
• Normal colonoscopy performed within 10 years prior to study participation, unless the subjects are <50 years old and without alarm signs and/or symptoms
• Subject signed the Informed Consent Form
• Female subjects must have a negative pregnancy test

Exclusion Criteria:

• 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
• History of gastroparesis
• Use of any of the following medications:
• Medications that may affect intestinal motility, prokinetics, 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 (NSAIDs)
• Subjects with pelvic floor dysfunction/defecatory disorder
• Participation in another clinical study within one month prior to screening.
• Women who are pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibrating Mode 1; Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)	Device: Vibrating Capsule; Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Experimental: Vibrating Mode 2; Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)	Device: Vibrating Capsule; Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
Sham Comparator: Sham; Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week)	Device: Sham capsule; Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Spontaneous Bowel Movement 1 success rate, and Complete Spontaneous Bowel Movement 2 success rate	Complete Spontaneous Bowel Movement 1 success rate is defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement during at least 6 of the 8 weeks of treatment, and Complete Spontaneous Bowel Movement 2 success rate is defined as an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement during at least 6 of the 8 weeks of treatment.	8 weeks

Collaborators and Investigators

• Sponsor: Vibrant Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: October 29, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 300CLD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No