Chronic Idiopathic ConstipationVibrantNCT03879239

Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation

A study testing Vibrating capsule in people with Chronic Idiopathic Constipation, run by Vibrant Ltd. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study is a prospective, randomized, multicenter, adaptive design, double blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic 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?: 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: 349 participants
Where: 8 sitesUnited States
Study dates: 8 Apr 2019to 5 Jan 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 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 ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 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 2. History of intestinal or colonic obstruction, or suspected intestinal obstruction.
3. 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) 4. History of gastroparesis 5. 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
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.
6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease 7. Presence of cardiac pacemaker or gastric electrical stimulator. 8. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
9. 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 10. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia 11. 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 12. Subjects with pelvic floor dysfunction/defecatory disorder, based on subject history 13. Participation in another clinical study within one month prior to screening.
14. Women who are pregnant or lactating 15. Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules 16. 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 17. Subject participated in a previous Vibrant study 18. Subjects planning to undergo MRI during the study 19. Any known allergy to soybean or beeswax or Calcium Carbonate 20. 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

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Augusta University
Augusta, Georgia, 30912
Great Lakes Medical Research LLC
Beachwood, Ohio, 44122
G & L Research, LLC.
Foley, Alabama, 36535
PharmQuest
Greensboro, North Carolina, 27408
Clinical Inquest Center Ltd
Huber Heights, Ohio, 45424
Clinical Neuroscience Solutions dba CNS Healthcare
Memphis, Tennessee, 38119
Great Lakes Gastroenterology Research
Mentor, Ohio, 44060
Del Sol Research Management
Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: A Prospective, Randomized, Multi-center, Double-Blinded, Placebo-Controlled, 3-Arm Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule, for the Treatment of Chronic Idiopathic Constipation

Read the detailed description

Subjects came 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

Three arms were assessed:

Vibrant Capsule mode A administered 5 times per week
Vibrant Capsule mode B administered 5 times per week
Placebo Capsule administered 5 times per week The difference between the 2 operating modes is in the vibrating sequence during the capsule's operating time.

Following Interim Analysis one active arm was dropped and the study continued with 2 arms, placebo and an active arm.

Conditions: Chronic Idiopathic Constipation
Being tested: Vibrating capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vibrating capsuleDevice
Vibrating Capsule administered 5 times per week

Study groups in NCT03879239
Study group	Role	What they receive
Vibrant Capsule mode A	Active comparator	Vibrant Capsule mode A administered 5 times per week Receives: Device: Vibrating capsule
Vibrant Capsule mode B	Active comparator	Vibrant Capsule mode B administered 5 times per week. Based on the analysis of the first pre-define phase of the study, active mode B was discontinued, and the trial was completed using mode A. Therefore, study results are not available for arm B. Receives: Device: Vibrating capsule
Placebo Capsule	Placebo comparator	Placebo Capsule administered 5 times per week Receives: Device: Vibrating capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

CSBM1 & CSBM2 Success Rate
CSBM1Success Rate: defined as 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: defined as the number of subject 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.
The study will be deemed successful if either the CSBM1 or the CSBM2 success rate is statistically significantly higher in the active arm that was continued after the interim analysis (Vibrant Capsule Mode A), than in the placebo arm
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: 8 weeks of treatment

Secondary outcomes (3)

Change From Baseline in Average Straining
Change from baseline in average straining using (0-10) scale where "0" is no straining and "10" is unbearable straining
Measured: 8 weeks of treatment
Change From Baseline in Average 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: 8 weeks of treatment
Change From Baseline in Average Bloating
Change from baseline in average bloating using scale (0-10) for bloating where 0=No bloating and 10=Unbearable bloating
Measured: 8 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 20195 Jan 2022

First posted18 Mar 2019
Study start8 Apr 2019
Primary completion16 Jul 2021
Study completion5 Jan 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.
Publications (2)Papers the sponsor has linked to this study.
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
Model description: The study design initially comprised 3 arms: 2 active vibrating capsule arms (Modes A and B) and 1 placebo arm. Based on the analysis of the first pre-define phase of the study, active mode B was discontinued and the trial was completed using mode A. Therefore, study results are available only for active A and Placebo arms.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 349 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03879239
Sponsor's protocol ID: 270CLD
Acronym: Vibrant
Status last verified: Aug 2024
First submitted: 17 Feb 2019
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Rao SSC, Quigley EMM, Chey WD, Sharma A, Lembo AJ. Randomized Placebo-Controlled Phase 3 Trial of Vibrating Capsule for Chronic Constipation. Gastroenterology. 2023 Jun;164(7):1202-1210.e6. doi: 10.1053/j.gastro.2023.02.013. Epub 2023 Feb 21.
PubMed 36822371
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Chronic Idiopathic Constipation (CIC)
RecruitingObservational study
A Study of Prucalopride in Breastfeeding Women With Constipation
Chronic Idiopathic Constipation (CIC)

All Chronic Idiopathic Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Multi-center, Double-Blinded, Placebo-Controlled, 3-Arm Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule, for the Treatment of Chronic Idiopathic Constipation
ClinicalTrials.gov ID: NCT03879239
Acronym / sponsor ID: Vibrant / 270CLD
Conditions: Chronic Idiopathic Constipation
Study type: Interventional
Recruitment status: Completed
Enrolment: 349 participants (actual)
Lead sponsor: Vibrant Ltd.Industry (pharma, biotech, devices)
Study start: 8 Apr 2019 (actual)
Primary completion: 16 Jul 2021 (actual)
Study completion: 5 Jan 2022 (actual)
First posted: 18 Mar 2019 (actual)
Results: Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Three arms were assessed:

Vibrant Capsule mode A administered 5 times per week
Vibrant Capsule mode B administered 5 times per week
Placebo Capsule administered 5 times per week The difference between the 2 operating modes is in the vibrating sequence during the capsule's operating time.

Following Interim Analysis one active arm was dropped and the study continued with 2 arms, placebo and an active arm.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: The study design initially comprised 3 arms: 2 active vibrating capsule arms (Modes A and B) and 1 placebo arm. Based on the analysis of the first pre-define phase of the study, active mode B was discontinued and the trial was completed using mode A. Therefore, study results are available only for active A and Placebo arms.

Arm	Type	Receives
Vibrant Capsule mode A	Active comparator	Device: Vibrating capsuleVibrant Capsule mode A administered 5 times per week
Vibrant Capsule mode B	Active comparator	Device: Vibrating capsuleVibrant Capsule mode B administered 5 times per week. Based on the analysis of the first pre-define phase of the study, active mode B was discontinued, and the trial was completed using mode A. Therefore, study results are not available for arm B.
Placebo Capsule	Placebo comparator	Device: Vibrating capsulePlacebo Capsule administered 5 times per week

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 ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 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 (7 listed)

History of complicated/obstructive diverticular disease 2. History of intestinal or colonic obstruction, or suspected intestinal obstruction.
3. 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) 4. History of gastroparesis 5. 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
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.
6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease 7. Presence of cardiac pacemaker or gastric electrical stimulator. 8. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.

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 capsuleVibrating Capsule administered 5 times per week	Device	Placebo Capsule, Vibrant Capsule mode A, Vibrant Capsule mode B

Primary outcome

CSBM1 & CSBM2 Success Rate
Time frame: 8 weeks of treatment
CSBM1Success Rate: defined as 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: defined as the number of subject 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. The study will be deemed successful if either the CSBM1 or the CSBM2 success rate is statistically significantly higher in the active arm that was continued after the interim analysis (Vibrant Capsule Mode A), than in the placebo arm 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.

3 secondary outcomes

Change From Baseline in Average Straining
Time frame: 8 weeks of treatment
Change From Baseline in Average Stool Consistency
Time frame: 8 weeks of treatment
Change From Baseline in Average Bloating
Time frame: 8 weeks of treatment

Results and safety

Results posted to the registry on 9 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vibrant Capsule Mode A	163	141
Vibrant Capsule Mode B	37	30
Placebo Capsule	149	133

Primary outcome: CSBM1 & CSBM2 Success Rate

Time frame: 8 weeks of treatment. Count of participants. Unit: Participants

Measure	Vibrant Capsule Mode A n = 163	Placebo Capsule n = 149
CSBM1 Success Rate	64	33
CSBM2 Success Rate	37	17

Vibrant Capsule Mode A vs Placebo Capsule: p = 0.0011, Chi-squared
Vibrant Capsule Mode A vs Placebo Capsule: p = 0.0085, Chi-squared

Population analysed: A predefined first-phase analysis was included in the protocol and approved by the FDA. The objective of this first phase analysis was to identify which of the 2 activation modes was superior, and to recommend that mode for the remainder of the study. Based on the analysis of the study's first phase, mode B was discontinued, and the trial was completed using mode A. Hence, per the pre-specified outcomes definition, the results are available for mode A \&Placebo arms without the dropped Arm B.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The Safety reporting conducted throughout the treatment period (8 weeks). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vibrant Capsule Mode A	0 of 163 (0%)	43 of 163 (26.4%)	0 of 163
Vibrant Capsule Mode B	0 of 37 (0%)	9 of 37 (24.3%)	0 of 37
Placebo Capsule	2 of 149 (1.3%)	26 of 149 (17.4%)	0 of 149

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36822371Rao SSC, Quigley EMM, Chey WD, Sharma A, Lembo AJ. Randomized Placebo-Controlled Phase 3 Trial of Vibrating Capsule for Chronic Constipation. Gastroenterology. 2023 Jun;164(7):1202-1210.e6. doi: 10.1053/j.gastro.2023.02.013. Epub 2023 Feb 21.
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

Related trials for Chronic Idiopathic Constipation

Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Chronic Idiopathic Constipation (CIC)
RecruitingObservational study
A Study of Prucalopride in Breastfeeding Women With Constipation
Chronic Idiopathic Constipation (CIC)

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.

8 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 Chronic Idiopathic Constipation, run by Vibrant Ltd. at 8 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 7 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 Aug 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 & CSBM2 Success Rate (time frame: 8 weeks of treatment). 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 NCT03879239, which also lists 2 linked publications.

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 Aug 2024.