ConstipationNCT02829047
Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration
A study testing Vibrating Capsule in people with Constipation, run by Vibrant Ltd. at 4 sites in United States.
Trial summary
The study is a prospective, multicenter, open-label, single-arm study, to evaluate the tolerability, safety and efficacy of the Vibrant Capsule in relieving 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?
- Vibrating Capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2016to Mar 2017
- 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
- Patients aged 22 years and older
- Patients with Chronic Idiopathic Constipation 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)
- Patients with an average of less than 3 Spontaneous Bowel Movements per week and at least 1 Spontaneous Bowel Movements per week
- Normal colonoscopy performed within 10 years prior to study participation, unless the patients are less than 50 years old and without alarm signs and/or symptoms
- Patient signed the Informed Consent Form
- Female subjects must have a negative urine pregnancy test 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; in these circumstances, a urine 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-depressants, anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium hydroxide
Show all 19Show 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: chronic use is defined as taking full dose non-steroidal anti-inflammatory drugs more than three times a week for at least six months. Patients on cardiac doses of aspirin may be enrolled in the study
- Patients with pelvic floor dysfunction/defecatory disorder, based on patient 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
- Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Albuquerque Neuroscience
Albuquerque, New Mexico, 87109
Avant Guntersville
Guntersville, Alabama, 35976
Borland-Groover Clinic
Jacksonville, Florida, 32256
Floridian Research Institute
Miami, Florida, 33145
About this study
Official title: A Prospective, Multicenter, Open-label, Single-arm Study to Assess the Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration
The study is a prospective, multicenter, open-label, single-arm study, to evaluate the tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation.
Read the detailed description
One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2 days, followed by one day without, one per day for 2 days followed by one day without, etc. (14 capsules in 3 weeks).
The study will have one interim analysis.
Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks.
Data reporting will be done on an electronic Case Report Form and an eDiary. During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation.
After 14 days the patients will return and eligibility will be re-assessed. Patients will be trained on how to use the base unit.
Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period.
Patients will receive phone calls up to twice per week and patient compliance will be monitored during the 8 weeks of the study.
- Conditions
- Constipation
- Being tested
- Vibrating Capsule
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating CapsuleDevice
Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Vibrating Capsule | Other | Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks) Receives: Device: Vibrating Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Bowel Movements Success Rate
Defined as the number of subjects with an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 3 of the 6 weeks of treatment. Subjects with less than 2 weeks (with at least 5 days per week) of valid diary during the treatment period will be considered as non-evaluable.
Measured: 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Study halted at interim analysis to allow the sponsor to focus on a new study with different design.
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrant Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eamonn Quigley, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829047
- Sponsor's protocol ID
- 220CLD
- Status last verified
- Mar 2017
- First submitted
- 5 Jul 2016
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data from this study will be published in Vibrant's future publications
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, Open-label, Single-arm Study to Assess the Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration
- ClinicalTrials.gov ID
- NCT02829047
- Acronym / sponsor ID
- 220CLD
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted at interim analysis to allow the sponsor to focus on a new study with different design.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Vibrant Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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 study is a prospective, multicenter, open-label, single-arm study, to evaluate the tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation.
Detailed description
One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2 days, followed by one day without, one per day for 2 days followed by one day without, etc. (14 capsules in 3 weeks).
The study will have one interim analysis.
Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks.
Data reporting will be done on an electronic Case Report Form and an eDiary. During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation.
After 14 days the patients will return and eligibility will be re-assessed. Patients will be trained on how to use the base unit.
Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period.
Patients will receive phone calls up to twice per week and patient compliance will be monitored during the 8 weeks of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrating Capsule | Other | Device: Vibrating CapsulePatients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 22 years and older
- Patients with Chronic Idiopathic Constipation 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)
- Patients with an average of less than 3 Spontaneous Bowel Movements per week and at least 1 Spontaneous Bowel Movements per week
- Normal colonoscopy performed within 10 years prior to study participation, unless the patients are less than 50 years old and without alarm signs and/or symptoms
- Patient signed the Informed Consent Form
Key exclusion criteria (19 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 |
|---|---|---|
| Vibrating CapsulePatients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks) | Device | Vibrating Capsule |
Primary outcome
Spontaneous Bowel Movements Success Rate
Time frame: 6 weeks of treatment
Defined as the number of subjects with an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 3 of the 6 weeks of treatment. Subjects with less than 2 weeks (with at least 5 days per week) of valid diary during the treatment period will be considered as non-evaluable.
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. Data from this study will be published in Vibrant's future publications
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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.
Eamonn Quigley, MD principal investigator
The Methodist Hospital Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating Capsule in people with Constipation, run by Vibrant Ltd. at 4 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 19 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: stopped early, 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 4 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. 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 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?
Spontaneous Bowel Movements Success Rate (time frame: 6 weeks of treatment). 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.