Clinical trial NCT05036369: Vibrant Capsule vs. Placebo for Patient Suffering From Constipation
Official title: A Prospective, Randomized, Multi-center, Double-Blinded, Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Placebo, for the Treatment of Chronic Idiopathic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation Chronic Idiopathic
Keywords: Constipation
Vibrating capsule
Chronic Idiopathic Constipation
Lead sponsor: Vibrant Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
Primary purpose: TREATMENT

Brief summary: The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week

Detailed description: The study is a prospective, randomized, multicenter, adaptive design, double blinded clinical study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.

Two arms will be assessed (at a ratio of 1:1 of Vibrant Treatment vs. placebo):

* Vibrant Capsule administered twice a week (Monday and Thursday)
* Placebo Capsule administered twice a week (Monday and Thursday) Subjects will come 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.

During the entire study period subjects will be asked to refrain from taking any medications or supplements to relieve their constipation.

Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement

Eligibility criteria: Inclusion Criteria:

1. Subjects aged 22 years and older
2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome IV criteria
3. Subjects who have not experienced relief of their symptoms from one or more available therapies (for at least one month at recommended dose) or unable to tolerate these therapies
4. Subjects with an average of ≤2.5 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM per week (as a result of at least 1 SBM and not more than 3 SBMs during each of the run-in weeks)
5. Subjects above 50 years old or \<50 years old and with alarm signs should have colonoscopy performed within 10 years prior to study participation. Colonoscopy results should exclude GI obstruction and/or GI malignancy
6. Subject signed the Informed Consent Form (ICF)
7. 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.

Exclusion Criteria:

1. 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. Clinical evidence of current and significant gastroparesis
5. Use of any of the following medications:

   * Medications that may affect intestinal motility (including but not limited to prokinetics, anti-Parkinsonian medications, opiates, opioids, Verapamil, Nifedipine, iron, magnesium supplements, Tricyclic antidepressants (TCAs), Heparin, Warfarin and Baclofen.
   * With the exception of antidepressants (other than TCAs), 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, gastric electrical stimulator or any electrical implanted device.
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 capsule's transit
10. History of Zenker's diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis 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 interventional 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, beeswax, Calcium Carbonate, Gelatin, Glycerin or Titanium dioxide
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

Primary outcomes:
measure: CSBM 1 Success Rate
timeFrame: up to 8 weeks of treatment
measure: CSBM2 Success Rate
timeFrame: up to 8 weeks of treatment
Secondary outcomes:
measure: Straining Based on the Subject's Assessment Recorded in Daily Diaries
timeFrame: up to 10 weeks
measure: CSBM1 Expanded Success Rate,
timeFrame: up to 8 weeks of treatment
measure: CSBM2 Expanded Success Rate
timeFrame: up to 8 weeks of treatment
measure: Change From Baseline in Stool Consistency
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Westminster
country: United States
facility: Advanced Rx Clinical Research Group, Inc
state: California
city: Cutler Bay
country: United States
facility: American Research Institute, INC
state: Florida
Study officials:
affiliation: Vibrant Ltd.
name: Tal Malina, MBA
role: STUDY_DIRECTOR
References: