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

Primary Purpose

Constipation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vibrating 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 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

Sites / Locations

Hope Clinical Research
Albuquerque Neuroscience
Great Lakes Medical Research
Health Research of Hampton Roads

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

Vibrating Mode 1

Vibrating Mode 2

Sham

Arm Description

Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)

Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03329027

First Posted

October 29, 2017

Last Updated

May 21, 2018

Sponsor

Vibrant Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03329027

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 14, 2017 (Actual)

Primary Completion Date

March 30, 2018 (Actual)

Study Completion Date

March 30, 2018 (Actual)

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

5. Study Description

Brief Summary

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.

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

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vibrating Mode 1

Arm Type

Experimental

Arm Description

Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)

Arm Title

Vibrating Mode 2

Arm Type

Experimental

Arm Description

Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week)

Intervention Type

Device

Intervention Name(s)

Vibrating Capsule

Intervention Description

Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)

Intervention Type

Device

Intervention Name(s)

Sham capsule

Intervention Description

Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)

Primary Outcome Measure Information:

Title

Complete Spontaneous Bowel Movement 1 success rate, and Complete Spontaneous Bowel Movement 2 success rate

Description

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 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

Facility Information:

Facility Name

Hope Clinical Research

City

Canoga Park

State/Province

California

ZIP/Postal Code

91303

Country

United States

Facility Name

Albuquerque Neuroscience

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Great Lakes Medical Research

City

Willoughby

State/Province

Ohio

ZIP/Postal Code

44094

Country

United States

Facility Name

Health Research of Hampton Roads

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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