Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)

NCT04458675 | Completed Phase 4 Results FDA Device

• 1 other identifier: 250CLD
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (2)

• CSBM1 Success Rate

  The number of subjects with 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 Success Rate:

  The number of participants with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movements (CSBM) during at least 6 of the 8 weeks of treatment

  8 weeks

Study Arms (2)

Active

EXPERIMENTAL

Active capsule

Device: Vibrant capsule

Placebo

PLACEBO COMPARATOR

Placebo capsule

Drug: Placebo

Interventions

Vibrant capsule DEVICE

The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility

Also known as: medical device

Active

Placebo DRUG

A biodegradable capsule, which visually similar to the Vibrant active capsule

Also known as: control

Placebo

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 (osmotic and stimulant laxatives used for at least one month at recommended dose)
• Subjects with an average of \<3 Spontaneous Bowel Movements (SBM) per week
• Normal colonoscopy performed within 5 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 blood pregnancy test during screening, confirmed by a negative urine pregnancy test during baseline and must not be lactating prior to receiving study medication. For females of child-bearing potential, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. All other female subjects must have the reason for their inability to bear children documented in the medical record \[i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)\]; in these circumstances, a pregnancy test will not be necessary

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-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): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study
• Subjects with pelvic floor dysfunction/defecatory disorder, based on subject history
• Participation in another clinical study within one month prior to screening.

Sponsors & Collaborators

• Vibrant Ltd.: lead

Study Sites (1)

Health Research of Hampton Roads

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Interventions

Equipment and Supplies

Results Point of Contact

• Title: Tal Malina / Clinical trials manager
• Organization: Vibrant LTD

tal.m@vibrantgastro.com

+972 046663322

Study Officials

• Tal Malina, B.SC MBA

  tal.m@vibrantgastro.com

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: July 7, 2020
• Study Start: July 26, 2018
• Primary Completion: January 7, 2019
• Study Completion: March 30, 2019
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)