Vibrant Capsule vs. Placebo for Patient Suffering From Constipation

NCT05036369 | Completed Results DMC FDA Device

• 1 other identifier: 280CLD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week

Conditions

Constipation Chronic Idiopathic

Keywords

Constipation; Vibrating capsule; Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (2)

• CSBM 1 Success Rate

  CSBM1 Success Rate: defined as the number of Participants 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. NOTE: A spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver. A complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.

  up to 8 weeks of treatment

• CSBM2 Success Rate

  CSBM2 Success Rate: defined as the number of Participants with 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. NOTE: A spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver. A complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.

  up to 8 weeks of treatment

Secondary Outcomes (4)

• Straining Based on the Subject's Assessment Recorded in Daily Diaries

  up to 10 weeks

• CSBM1 Expanded Success Rate,

  up to 8 weeks of treatment

• CSBM2 Expanded Success Rate

  up to 8 weeks of treatment

• Change From Baseline in Stool Consistency

  up to 10 weeks

Study Arms (2)

Active capsule

EXPERIMENTAL

The Vibrant non-biodegradable capsule administrated twice a week

Device: Vibrant capsule

Placebo

PLACEBO COMPARATOR

The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week

Device: Placebo capsule

Interventions

Vibrant capsule DEVICE

Vibrant capsule - Administered twice a week (Monday and Thursday).

Active capsule

Placebo capsule DEVICE

Placebo Capsule administered twice a week (Monday and Thursday)

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 IV criteria
• Subjects who have not experienced relief of their symptoms from one or more available therapies (for at least one month at recommended dose) or unable to tolerate these therapies
• Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week (as a result of at least 1 SBM and not more than 3 SBMs during each of the run-in weeks)
• Subjects above 50 years old or \<50 years old and with alarm signs should have colonoscopy performed within 10 years prior to study participation. Colonoscopy results should exclude GI obstruction and/or GI malignancy
• 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)
• Clinical evidence of current and significant gastroparesis
• Use of any of the following medications:
• Medications that may affect intestinal motility (including but not limited to prokinetics, anti-Parkinsonian medications, opiates, opioids, Verapamil, Nifedipine, iron, magnesium supplements, Tricyclic antidepressants (TCAs), Heparin, Warfarin and Baclofen.
• With the exception of antidepressants (other than TCAs), 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, gastric electrical stimulator or any electrical implanted device.
• 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 capsule's transit
• History of Zenker's diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis 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 interventional clinical study within one month prior to screening.

Sponsors & Collaborators

• Vibrant Ltd.: lead

Study Sites (2)

Advanced Rx Clinical Research Group, Inc

Westminster, California, 92683, United States

Location

American Research Institute, INC

Cutler Bay, Florida, 33157, United States

Location

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 trials manager
• Organization: VibrantGastro

service@vibrantgastro.com

+972 046663322

Study Officials

• Tal Malina, MBA

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study. The subjects and the evaluators will be blinded to the treatment allocated to each subject. Each site will assign an unblinded person that will handle all issues related to capsule administration and accountability. The unblinded person will not be involved in any subject's assessments. Rest of the site staff will remain blind throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: September 5, 2021
• Study Start: July 5, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: July 9, 2024
• Results First Posted: July 9, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)