Chronic Idiopathic ConstipationPhase 4CICNCT04458675
Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)
A Phase 4 study testing Vibrant capsule in people with Chronic Idiopathic Constipation, run by Vibrant Ltd. at 1 site in United States.
Trial summary
The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Idiopathic Constipation
- 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
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 30 Mar 2019
- Phase
- Phase 4
- 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 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
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)
- 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
Show all 20Show fewer
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Research of Hampton Roads
Newport News, Virginia, 23606
About this study
Official title: A Prospective, Multicenter, Randomized, Single Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)
The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.
Read the detailed description
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:
- Daily BM, SBM, CSBM
- Change of their diet, if applicable (NOTE: the protocol will not ask/require the subjects to change anything in his/her diet)
- Change in sympotms as: brisol stool consistancy, straining, bloating, and the other questions in the eDiary
- Medication
- AE (including diarhrea)
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
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- Vibrant capsule, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrant capsuleDevice
Also called medical device
The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility
PlaceboDrug
Also called control
A biodegradable capsule, which visually similar to the Vibrant active capsule
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Active capsule Receives: Device: Vibrant capsule |
| Placebo | Placebo comparator | Placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start26 Jul 2018
- Primary completion7 Jan 2019
- Study completion30 Mar 2019
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 Chronic Idiopathic ConstipationStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrant Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tal Malina, B.SC MBA, Study director, tal.m@vibrantgastro.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458675
- Sponsor's protocol ID
- 250CLD
- Acronym
- CIC
- Status last verified
- May 2024
- First submitted
- 9 Jun 2020
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Single Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)
- ClinicalTrials.gov ID
- NCT04458675
- Acronym / sponsor ID
- CIC / 250CLD
- Conditions
- Chronic Idiopathic Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Vibrant Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Posted 14 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.
Detailed description
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:
- Daily BM, SBM, CSBM
- Change of their diet, if applicable (NOTE: the protocol will not ask/require the subjects to change anything in his/her diet)
- Change in sympotms as: brisol stool consistancy, straining, bloating, and the other questions in the eDiary
- Medication
- AE (including diarhrea)
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Vibrant capsuleActive capsule |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (20 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)
- History of 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 capsuleAlso: medical deviceThe capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility | Device | Active |
| PlaceboAlso: controlA biodegradable capsule, which visually similar to the Vibrant active capsule | Drug | Placebo |
Primary outcome
CSBM1 Success Rate
Time frame: 8 weeks
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
CSBM2 Success Rate:
Time frame: 8 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 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, B.SC MBA study director
tal.m@vibrantgastro.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vibrant capsule in people with Chronic Idiopathic Constipation, run by Vibrant Ltd. at 1 site 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 6 inclusion and 20 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 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 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?
CSBM1 Success Rate (time frame: 8 weeks). 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 14 Jun 2024.