Chronic Idiopathic ConstipationNCT02030756
Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals
A study testing vibrating capsule in people with Chronic Idiopathic Constipation, run by Vibrant Ltd. at 18 sites in 2 countries.
Trial summary
This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Idiopathic Constipation
- What is being tested?
- vibrating 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
- 144 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jul 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 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 which was used for at least one month at recommended dose).
- Patients with more than 1 bowel movement/2 weeks and < 3 bowel movement/week.
- Colonoscopy performed in the past 10 years prior to study participation, unless the patients are <50 years old and without alarming signs and symptoms
- Patient signed ICF
- For women with childbearing potential, adequate contraception
Who cannot join
- History of complicated/obstructive diverticular disease
- History of intestinal or colonic obstruction.
- History of significant GI disorder.
- Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids
- Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.
- Presence of pacemaker.
Show all 13Show fewer
- History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
- Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality, including GI resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia.
- History of Zenker's diverticulum, dysphagia or a known esophageal stricture 10. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
- 11. Participation in another clinical study in the last 4 months prior to screening.
- 12. 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 clinical study.
- 13. Women who are pregnant or lactating.
- -
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States11 sites
Albuquerque Neuroscience
Albuquerque, New Mexico, 87109
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Georgia Regents University
Augusta, Georgia, 30912
Mgh Boston
Boston, Massachusetts, 02114
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Huoston Methodist Hosptial
Houston, Texas, 77030
Borland-Groover Clinic
Jacksonville, Florida, 32256
NYU Langone Medical Center
New York, New York, 10016
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
CTRS LLC
Pittsburgh, Pennsylvania, 15206
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Israel7 sites
Bat-Yamon
Bat Yam
Degani center Clalit MC
Hadera
Expert clinic Clalit MC
Herzliya
Talpiot clinic Clalit MC
Jerusalem
Zvoulon MC Clalit MC
Kiryat Bialik
100 Tower
Tel Aviv
Souraski Medical Center
Tel Aviv
About this study
Official title: Assessment of the Performance, Efficacy and Safety of Vibrating Capsule Medical Device in Aiding Reliving Constipated Individuals.
This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- vibrating capsule, sham non-vibrating capsule
- Keywords
- constipation
- 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 8 weeks of treatment [1 every 3 days (+/- 1 day)].
sham non-vibrating capsuleDevice
patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
| Study group | Role | What they receive |
|---|---|---|
| Vibrating capsule | Active comparator | patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. Receives: Device: vibrating capsule |
| sham non-vibrating capsule | Sham comparator | patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. Receives: Device: sham non-vibrating capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of bowel movements
change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrant Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030756
- Sponsor's protocol ID
- Vibrant-14-MS-CTIL
- Status last verified
- Nov 2017
- First submitted
- 7 Jan 2014
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Performance, Efficacy and Safety of Vibrating Capsule Medical Device in Aiding Reliving Constipated Individuals.
- ClinicalTrials.gov ID
- NCT02030756
- Acronym / sponsor ID
- Vibrant-14-MS-CTIL
- Conditions
- Chronic Idiopathic Constipation
- Keywords
- constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Vibrant Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibrating capsule | Active comparator | Device: vibrating capsulepatients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. |
| sham non-vibrating capsule | Sham comparator | Device: sham non-vibrating capsulepatients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 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 which was used for at least one month at recommended dose).
- Patients with more than 1 bowel movement/2 weeks and < 3 bowel movement/week.
- Colonoscopy performed in the past 10 years prior to study participation, unless the patients are <50 years old and without alarming signs and symptoms
- Patient signed ICF
Key exclusion criteria (13 listed)
- History of complicated/obstructive diverticular disease
- History of intestinal or colonic obstruction.
- History of significant GI disorder.
- Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids
- Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.
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 8 weeks of treatment [1 every 3 days (+/- 1 day)]. | Device | Vibrating capsule |
| sham non-vibrating capsulepatients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. | Device | sham non-vibrating capsule |
Primary outcome
Frequency of bowel movements
Time frame: 3 months
change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vibrating capsule in people with Chronic Idiopathic Constipation, run by Vibrant Ltd. at 18 sites in 2 countries.
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 13 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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of bowel movements (time frame: 3 months). 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 7 Nov 2017.