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The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.
Visit 1 -Screening: Subjects will be screened to the study at the screening visit, PAC-QOL questionnaire will be completed and subject will have a run-in time for a period of 2-3 weeks, assuring 14 consecutive days of eDiary with an average of < 3 SBM per week.
Visit 2 - Baseline: After the run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be randomized to either Vibrant or Vibrant placebo for a treatment period of 8 weeks. Subjects, in both arms, will have their first administration of Vibrant capsule / Vibrant placebo on site at the day of baseline visit and will be instructed on their treatment administration at home and will be requested to ingest the capsules at a specific time of the day. At baseline, subjects will also be trained on how to use the base unit at home.
Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study (including the run-in period).
The eDiary will include questions on:
The first 2 weeks of treatment will be considered as a subjects' training period.
Visit 3 -after 4 weeks of treatment - an on site visit will take place to evaluate subject's safety and treatment efficacy and additional capsule dispencing.
Visit 4 Final visit -after another 4 weeks of treatment - an on site visit will take place to evaluate subject's safety and treatment efficacy and collect the base unites and remaning capsules. PAC-QOL, Ease of use and TSQM questionnaires will be completed.
During the entire study period, 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.
Subjects will receive phone calls at least once a week and subject compliance will be monitored throughout the 8 weeks of the study.
Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement.
Data about time of activation of the capsules will be automatically registered and transmitted by the base unit for Vibrant capsules
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Active capsule |
|
| Placebo | Placebo Comparator | Placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrant capsule | Device | The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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)
History of 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 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.
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
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, B.SC MBA | tal.m@vibrantgastro.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Research of Hampton Roads | Newport News | Virginia | 23606 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Active capsule Vibrant capsule: The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility |
| FG001 | Placebo | Placebo capsule Placebo: A biodegradable capsule, which visually similar to the Vibrant active capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Active capsule Vibrant capsule: The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility |
| BG001 | Placebo | Placebo capsule Placebo: A biodegradable capsule, which visually similar to the Vibrant active capsule |
| 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 | 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 | Posted | Count of Participants | Participants | 8 weeks |
|
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 | Active capsule Vibrant capsule: The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tal Malina / Clinical trials manager | Vibrant LTD | +972 046663322 | tal.m@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 | Oct 7, 2018 | May 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Placebo | Drug | A biodegradable capsule, which visually similar to the Vibrant active capsule |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of constipation | Mean | Standard Deviation | years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 6 |
| 31 |
| EG001 | Placebo | Placebo capsule Placebo: A biodegradable capsule, which visually similar to the Vibrant active capsule | 0 | 28 | 0 | 28 | 8 | 28 |
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
Permission to use study data is required