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.
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
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.
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
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
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Vibrant Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tal Malina, MBA, Study director, Vibrant Ltd.
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 36822371Rao 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