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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031301
Recruitment Status : Unknown
Verified January 2018 by Vibrant Ltd..
Recruitment status was:  Recruiting
First Posted : January 25, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Vibrant Ltd.

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.


Condition or disease Intervention/treatment Phase
Constipation Device: Vibrant capsule Device: Sham capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: Vibrant capsule
Patients will receive the Vibrant capsule 5 times a week for 8 weeks of treatment
Device: Vibrant capsule
One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.

Sham Comparator: Sham capsule
Patients will receive the sham capsule (activated, non-vibrating) 5 times a week for 8 weeks of treatment
Device: Sham capsule
One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.




Primary Outcome Measures :
  1. 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. [ Time Frame: 8 weeks ]
    Complete Spontaneous Bowel Movements



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of complicated/obstructive diverticular disease
  2. History of intestinal or colonic obstruction, or suspected intestinal obstruction.
  3. 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)
  4. History of gastroparesis
  5. 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.
  6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease.
  7. Presence of cardiac pacemaker or gastric electrical stimulator.
  8. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
  9. 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
  10. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia
  11. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
  12. Subjects with pelvic floor dysfunction/defecatory disorder
  13. Participation in another clinical study within one month prior to screening.
  14. Women who are pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031301


Contacts
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Contact: Dvora Darky +972-4-6660885 dvora.d@vibrantgastro.com
Contact: Lior Ben Tsur

Locations
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United States, Alabama
Avant Guntersville Recruiting
Guntersville, Alabama, United States, 35976
Contact: Cynthia Abath         
Principal Investigator: William A Nixon, MD         
United States, Florida
Floridian Research Institute Recruiting
Miami, Florida, United States, 33145
Contact: Milene Garcia         
Principal Investigator: Jorge Loredo, MD         
Sponsors and Collaborators
Vibrant Ltd.
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Responsible Party: Vibrant Ltd.
ClinicalTrials.gov Identifier: NCT03031301    
Other Study ID Numbers: 240CLD
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
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.: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive