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

NCT03879239 | Completed Results DMC FDA Device

• 1 other identifier: 270CLD
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks of treatment

Secondary Outcomes (3)

• Change From Baseline in Average Straining

  8 weeks of treatment

• Change From Baseline in Average Stool Consistency

  8 weeks of treatment

• Change From Baseline in Average Bloating

  8 weeks of treatment

Other Outcomes (2)

• Change in SBM

  8 weeks of treatment

• Change From Baseline in Quality of Life

  8 weeks of treatment

Study Arms (3)

Vibrant Capsule mode A

ACTIVE COMPARATOR

Vibrant Capsule mode A administered 5 times per week

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.

Device: Vibrating capsule

Placebo Capsule

PLACEBO COMPARATOR

Placebo Capsule administered 5 times per week

Device: Vibrating capsule

Interventions

Vibrating capsule DEVICE

Vibrating Capsule administered 5 times per week

Placebo Capsule; Vibrant Capsule mode A; Vibrant Capsule mode B

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of complicated/obstructive diverticular disease 2. 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) 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.
• \. 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.
• \. 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.
• \. 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

Sponsors & Collaborators

• Vibrant Ltd.: lead

Study Sites (8)

G & L Research, LLC.

Foley, Alabama, 36535, United States

Location

Del Sol Research Management

Tucson, Arizona, 85712, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

Great Lakes Medical Research LLC

Beachwood, Ohio, 44122, United States

Location

Clinical Inquest Center Ltd

Huber Heights, Ohio, 45424, United States

Location

Great Lakes Gastroenterology Research

Mentor, Ohio, 44060, United States

Location

Clinical Neuroscience Solutions dba CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Related Publications (2)

• 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.

  PMID: 36822371 DERIVED

• 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.

  PMID: 32449277 DERIVED

Results Point of Contact

• Title: Tal Malina / Clinical trials manager
• Organization: Vibrant LTD

tal.m@vibrantgastro.com

+972 046663322

Study Officials

• Tal Malina, MBA

  Vibrant Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This was a double blind, placebo controlled study and both the participant and the investigator were masked. The study investigators, sponsors and participants were all blinded throughout the study. A research pharmacist/investigator who was not involved with evaluating patients or conducting the study, provided training to the participants and dispensed the correct study arm allocation. This individual had no other role in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2019
• First Posted: March 18, 2019
• Study Start: April 8, 2019
• Primary Completion: July 16, 2021
• Study Completion: January 5, 2022
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)