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The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
The study is a prospective, randomized, multicenter, adaptive design, double blinded clinical study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.
Two arms will be assessed (at a ratio of 1:1 of Vibrant Treatment vs. placebo):
During the entire study period subjects will be asked to refrain from taking any medications or supplements to relieve their constipation.
Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active capsule | Experimental | The Vibrant non-biodegradable capsule administrated twice a week |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrant capsule | Device | Vibrant capsule - Administered twice a week (Monday and Thursday). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Straining Based on the Subject's Assessment Recorded in Daily Diaries | Change from baseline in average straining based on the subject's account in daily diary reports. The straining level reported by the patient on a scale ranged from 0 - No straining to 10 Unbearable straining. | up to 10 weeks |
| CSBM1 Expanded Success Rate, |
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Inclusion Criteria:
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 (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:
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.
Women who are pregnant or lactating
Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules
Inability to use an electronic daily Diary (on a computer, phone application, tablet or other electronic device) to report bowel movements, symptoms and medication usage
Subject participated in a previous Vibrant study
Subjects planning to undergo MRI during the study
Any known allergy to soybean, beeswax, Calcium Carbonate, Gelatin, Glycerin or Titanium dioxide
Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
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| Name | Affiliation | Role |
|---|---|---|
| Tal Malina, MBA | Vibrant Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Rx Clinical Research Group, Inc | Westminster | California | 92683 | United States | ||
| American Research Institute, INC |
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Following the consent process, subjects who met the study criteria started a run-in period of 2-4 weeks, during which they completed a daily eDiary with questions regrading their bowel movements and constipation symptoms.
The study recruitment was conducted in 30 clinical sites in the USA from June 2021- September 2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Capsule | The Vibrant non-biodegradable capsule administrated twice a week Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday). |
| FG001 | Placebo | The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Capsule | The Vibrant non-biodegradable capsule administrated twice a week Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | mITT | Posted | Count of Participants | Participants | up to 8 weeks of treatment |
|
The Safety reporting conducted throughout the treatment period (8 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Capsule | The Vibrant non-biodegradable capsule administrated twice a week Vibrant capsule: Vibrant capsule - Administered twice a week (Monday and Thursday). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized due to bleeding from the catheter port | Renal and urinary disorders | Non-systematic Assessment | Hospitalized due to bleeding from the catheter port |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical trials manager | VibrantGastro | +972 046663322 | service@vibrantgastro.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2021 | Jun 13, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
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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.
| Placebo capsule | Device | Placebo Capsule administered twice a week (Monday and Thursday) |
|
CSBM1 expanded 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 5 of the 8 weeks of treatment. |
| up to 8 weeks of treatment |
| CSBM2 Expanded 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 5 of the 8 weeks of treatment. | up to 8 weeks of treatment |
| Change From Baseline in Stool Consistency | Change from baseline in average stool consistency, using the Bristol Stool Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass) and 7 =watery, no solid pieces, entirely liquid | up to 10 weeks |
| Cutler Bay |
| Florida |
| 33157 |
| United States |
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Age of constipation onset (years) | Mean | Standard Deviation | years |
|
| OG001 |
| Placebo |
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday) |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | up to 8 weeks of treatment |
|
|
|
| Secondary | Straining Based on the Subject's Assessment Recorded in Daily Diaries | Change from baseline in average straining based on the subject's account in daily diary reports. The straining level reported by the patient on a scale ranged from 0 - No straining to 10 Unbearable straining. | mITT | Posted | Mean | 95% Confidence Interval | units on a scale | up to 10 weeks |
|
|
|
| Secondary | CSBM1 Expanded Success Rate, | CSBM1 expanded 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 5 of the 8 weeks of treatment. | Posted | Count of Participants | Participants | up to 8 weeks of treatment |
|
|
|
| Secondary | CSBM2 Expanded 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 5 of the 8 weeks of treatment. | mITT | Posted | Count of Participants | Participants | up to 8 weeks of treatment |
|
|
|
| Secondary | Change From Baseline in Stool Consistency | Change from baseline in average stool consistency, using the Bristol Stool Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass) and 7 =watery, no solid pieces, entirely liquid | mITT | Posted | Mean | 95% Confidence Interval | units on a scale | up to 10 weeks |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 16 |
| 44 |
| EG001 | Placebo | The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week Placebo capsule: Placebo Capsule administered twice a week (Monday and Thursday) | 0 | 56 | 1 | 56 | 11 | 56 |
|
| Sensation of Vibration | Product Issues | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment | Heartburn |
|
| UTI | Renal and urinary disorders | Systematic Assessment | Urinary tract infections |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Vomiting |
|
| Fatigue | General disorders | Systematic Assessment | Fatigue |
|
| Esophageal Spasm | Gastrointestinal disorders | Systematic Assessment | Esophageal Spasm |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Nausea |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment | Gastroenteritis |
|
| Other | General disorders | Systematic Assessment |
|
Permission to use study data is required