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A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week

Primary Purpose

Constipation

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vibrant capsule

Sham capsule

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects aged 22 years and older
Subjects with Chronic Idiopathic Constipation (CIC) 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 (SBM) per week and ≥1 SBM 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 (ICF)
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 (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 (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

Sites / Locations

Avant GuntersvilleRecruiting
Floridian Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Vibrant capsule

Sham capsule

Arm Description

Patients will receive the Vibrant capsule 5 times a week for 8 weeks of treatment

Patients will receive the sham capsule (activated, non-vibrating) 5 times a week for 8 weeks of treatment

Outcomes

Primary Outcome Measures

Complete Spontaneous Bowel Movement (CSBM) success rate, defined as an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.

Complete Spontaneous Bowel Movements

Secondary Outcome Measures

Full Information

NCT ID

NCT03031301

First Posted

January 16, 2017

Last Updated

January 11, 2018

Sponsor

Vibrant Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03031301

Brief Title

A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week

Official Title

A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vibrant Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation. Two arms will be assessed: Vibrant Capsule administered 5 times per week Sham Capsule administered 5 times per week Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 8 weeks. Data reporting will be done on an electronic Case Report Form (eCRF) 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 14 days of 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vibrant capsule

Arm Type

Active Comparator

Arm Description

Patients will receive the Vibrant capsule 5 times a week for 8 weeks of treatment

Arm Title

Sham capsule

Arm Type

Sham Comparator

Arm Description

Patients will receive the sham capsule (activated, non-vibrating) 5 times a week for 8 weeks of treatment

Intervention Type

Device

Intervention Name(s)

Vibrant capsule

Intervention Description

One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.

Intervention Type

Device

Intervention Name(s)

Sham capsule

Intervention Description

One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.

Primary Outcome Measure Information:

Title

Description

Complete Spontaneous Bowel Movements

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects aged 22 years and older Subjects with Chronic Idiopathic Constipation (CIC) 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 (SBM) per week and ≥1 SBM 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 (ICF) 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 (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 (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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dvora Darky

Phone

+972-4-6660885

dvora.d@vibrantgastro.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lior Ben Tsur

Facility Information:

Facility Name

Avant Guntersville

City

Guntersville

State/Province

Alabama

ZIP/Postal Code

35976

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cynthia Abath

First Name & Middle Initial & Last Name & Degree

William A Nixon, MD

Facility Name

Floridian Research Institute

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Milene Garcia

First Name & Middle Initial & Last Name & Degree

Jorge Loredo, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32449277

Citation

Rao SSC, Lembo A, Chey WD, Friedenberg K, Quigley EMM. Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation. Neurogastroenterol Motil. 2020 Nov;32(11):e13890. doi: 10.1111/nmo.13890. Epub 2020 May 25.

Results Reference

derived

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A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week

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