ConstipationNCT03031301
A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week
A study testing Vibrant capsule in people with Constipation, run by Vibrant Ltd. at 2 sites in United States.
Trial summary
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- 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
- 182 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2017to 30 Jul 2018
- 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 III criteria and who have not experienced relief of their symptoms from available therapies
- Subjects with an average of <3 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week
- Normal colonoscopy performed within 10 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 pregnancy test
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-depressants, anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium hydroxide
Show all 16Show 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)
- Subjects with pelvic floor dysfunction/defecatory disorder
- Participation in another clinical study within one month prior to screening.
- Women who are pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Avant Guntersville
Guntersville, Alabama, 35976
Floridian Research Institute
Miami, Florida, 33145
About this study
Official title: A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.
Two arms will be assessed:
- Vibrant Capsule administered 5 times per week
- Sham Capsule administered 5 times per week
Read the detailed description
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.
Two arms will be assessed:
- Vibrant Capsule administered 5 times per week
- Sham Capsule administered 5 times per week
Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 8 weeks.
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.
After the 14 days of run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit.
Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period.
Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.
- Conditions
- Constipation
- Being tested
- Vibrant capsule, Sham capsule
- 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
One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.
Sham capsuleDevice
One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Vibrant capsule | Active comparator | Patients will receive the Vibrant capsule 5 times a week for 8 weeks of treatment Receives: Device: Vibrant capsule |
| Sham capsule | Sham comparator | Patients will receive the sham capsule (activated, non-vibrating) 5 times a week for 8 weeks of treatment Receives: Device: Sham capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
CSBM1 success rate, defined as 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- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
CSBM2 success rate, defined as an increase from the run-in period of at least 2 weekly Complete Spontaneous Bowel Movement (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 posted25 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrant Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dvora Darky, Study director, Vibrant Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031301
- Sponsor's protocol ID
- 240CLD
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2017
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data from this study will be presented in future Vibrantgastro publications.
Publications
Rao SSC, Lembo A, Chey WD, Friedenberg K, Quigley EMM. Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation. Neurogastroenterol Motil. 2020 Nov;32(11):e13890. doi: 10.1111/nmo.13890. Epub 2020 May 25.
PubMed 32449277
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week
- ClinicalTrials.gov ID
- NCT03031301
- Acronym / sponsor ID
- 240CLD
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Vibrant Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Posted 3 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 study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.
Two arms will be assessed:
- Vibrant Capsule administered 5 times per week
- Sham Capsule administered 5 times per week
Detailed description
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.
Two arms will be assessed:
- Vibrant Capsule administered 5 times per week
- Sham Capsule administered 5 times per week
Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 8 weeks.
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.
After the 14 days of run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit.
Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period.
Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibrant capsule | Active comparator | Device: Vibrant capsulePatients will receive the Vibrant capsule 5 times a week for 8 weeks of treatment |
| Sham capsule | Sham comparator | Device: Sham capsulePatients will receive the sham capsule (activated, non-vibrating) 5 times a week for 8 weeks of treatment |
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
- Subjects with an average of <3 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week
- Normal colonoscopy performed within 10 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 (16 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 capsuleOne Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment. | Device | Vibrant capsule |
| Sham capsuleOne Sham capsule will be ingested 5 times per week for 8 weeks of treatment. | Device | Sham capsule |
Primary outcome
CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
Time frame: 8 weeks
CSBM1 success rate, defined as 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- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment
Time frame: 8 Weeks
CSBM2 success rate, defined as an increase from the run-in period of at least 2 weekly Complete Spontaneous Bowel Movement (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 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32449277Rao SSC, Lembo A, Chey WD, Friedenberg K, Quigley EMM. Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation. Neurogastroenterol Motil. 2020 Nov;32(11):e13890. doi: 10.1111/nmo.13890. Epub 2020 May 25.
- Individual participant dataSharing planned: No. Data from this study will be presented in future Vibrantgastro publications.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
Dvora Darky 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, 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 6 inclusion and 16 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 3 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 3 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?
CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment (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?
On the ClinicalTrials.gov record for NCT03031301, which also lists 1 linked publication.
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 3 Jul 2024.