Constipation Chronic IdiopathicCapsuleNCT05036369
Vibrant Capsule vs. Placebo for Patient Suffering From Constipation
A study testing Vibrant capsule in people with Constipation Chronic Idiopathic, run by Vibrant Ltd. at 2 sites in United States.
Trial summary
The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Constipation Chronic Idiopathic
- What is being tested?
- Vibrant capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jul 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
American Research Institute, INC
Cutler Bay, Florida, 33157
Advanced Rx Clinical Research Group, Inc
Westminster, California, 92683
About this study
Official title: A Prospective, Randomized, Multi-center, Double-Blinded, Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Placebo, for the Treatment of Chronic Idiopathic Constipation
The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
Read the detailed description
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):
- Vibrant Capsule administered twice a week (Monday and Thursday)
- Placebo Capsule administered twice a week (Monday and Thursday) Subjects will come for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks.
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
- Conditions
- Constipation Chronic Idiopathic
- Being tested
- Vibrant capsule, Placebo capsule
- Keywords
- Constipation, Vibrating capsule, Chronic Idiopathic Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrant capsuleDevice
Vibrant capsule - Administered twice a week (Monday and Thursday).
Placebo capsuleDevice
Placebo Capsule administered twice a week (Monday and Thursday)
| Study group | Role | What they receive |
|---|---|---|
| Active capsule | Experimental | The Vibrant non-biodegradable capsule administrated twice a week Receives: 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 Receives: Device: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 8 weeks of treatment
Secondary outcomes (4)
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.
Measured: up to 10 weeks
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.
Measured: 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.
Measured: 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
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start5 Jul 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Constipation Chronic IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrant Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tal Malina, MBA, Study director, Vibrant Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036369
- Sponsor's protocol ID
- 280CLD
- Acronym
- Capsule
- Status last verified
- Jul 2023
- First submitted
- 2 Aug 2021
- Last updated
- 9 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-center, Double-Blinded, Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Placebo, for the Treatment of Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT05036369
- Acronym / sponsor ID
- Capsule / 280CLD
- Conditions
- Constipation Chronic Idiopathic
- Keywords
- Constipation, Vibrating capsule, Chronic Idiopathic Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vibrant Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 9 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
Detailed description
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):
- Vibrant Capsule administered twice a week (Monday and Thursday)
- Placebo Capsule administered twice a week (Monday and Thursday) Subjects will come for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
| Arm | Type | Receives |
|---|---|---|
| Active capsule | Experimental | Device: Vibrant capsuleThe Vibrant non-biodegradable capsule administrated twice a week |
| Placebo | Placebo comparator | Device: Placebo capsuleThe placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrant capsuleVibrant capsule - Administered twice a week (Monday and Thursday). | Device | Active capsule |
| Placebo capsulePlacebo Capsule administered twice a week (Monday and Thursday) | Device | Placebo |
Primary outcome
CSBM 1 Success Rate
Time frame: up to 8 weeks of treatment
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.
CSBM2 Success Rate
Time frame: up to 8 weeks of treatment
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.
4 secondary outcomes
Straining Based on the Subject's Assessment Recorded in Daily Diaries
Time frame: up to 10 weeks
CSBM1 Expanded Success Rate,
Time frame: up to 8 weeks of treatment
CSBM2 Expanded Success Rate
Time frame: up to 8 weeks of treatment
Change From Baseline in Stool Consistency
Time frame: up to 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tal Malina, MBA study director
Vibrant Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrant capsule in people with Constipation Chronic Idiopathic, run by Vibrant Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSBM 1 Success Rate (time frame: up to 8 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.