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

NCT03031301 | Completed Results DMC FDA Device

• 1 other identifier: 240CLD
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 2

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

Conditions

Constipation

Outcome Measures

Primary Outcomes (2)

• CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment

  CSBM1 success rate, defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment

  8 weeks

• CSBM2- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment

  CSBM2 success rate, defined as an increase from the run-in period of at least 2 weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment

  8 Weeks

Study Arms (2)

Vibrant capsule

ACTIVE COMPARATOR

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

Device: Vibrant capsule

Sham capsule

SHAM COMPARATOR

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

Device: Sham capsule

Interventions

Vibrant capsule DEVICE

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

Vibrant capsule

Sham capsule DEVICE

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

Sham capsule

Eligibility Criteria

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

You may qualify if:

• 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

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 (NSAIDs)
• Subjects with pelvic floor dysfunction/defecatory disorder
• Participation in another clinical study within one month prior to screening.

Sponsors & Collaborators

• Vibrant Ltd.: lead

Study Sites (2)

Avant Guntersville

Guntersville, Alabama, 35976, United States

Location

Floridian Research Institute

Miami, Florida, 33145, United States

Location

Related Publications (1)

• 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.

  PMID: 32449277 DERIVED

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 trial manager
• Organization: Vibrantgastro

service@vibrantgastro.com

046663322

Study Officials

• Dvora Darky

  Vibrant Ltd.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 25, 2017
• Study Start: February 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)