A Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes

Subjects will be followed continuously for at least a 2 weeks run-in period and then be randomized to either Vibrant or Sham capsules for a treatment period of 8 weeks. The first 2 weeks of treatment will be considered as a subjects' training period.

Data reporting will be done on an electronic Case Report Form and an eDiary. Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period.

After the run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit.

Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period.

Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.

• Vibrating Capsule (Device): Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
• Sham capsule (Device): Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)

Primary outcomes

• CSBM1- an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment [8 weeks]: CSBM1 success rate, defined as an increase from the base line of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment
• CSBM2- an Increase of at Least Two Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment [6-8 weeks]: CSBM2 success rate, defined as an increase from the base line of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.

Secondary outcomes

• SBM 1- Success Rate, Defined as as an Increase From the Base Line of at Least One Weekly Spontaneous Bowel Movement (SBM) During at Least 6 of the 8 Weeks of Treatment. [6-8 weeks]: SBM success rate, defined as as an increase from the base line of at least one weekly Spontaneous Bowel Movement (SBM) during at least 6 of the 8 weeks of treatment. Subjects with less than 2 weeks (with at least 5 days per week) of valid diary during the treatment period will be considered as non-evaluable.

Sex: All, ages: 22 Years to any

Inclusion Criteria:

* Subjects aged 22 years and older
* Subjects with Chronic Idiopathic Constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies
* Subjects with an average of <3 Spontaneous Bowel Movements per week and ≥1 Spontaneous Bowel Movements per week
* Normal colonoscopy performed within 10 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
* Female subjects must have a negative pregnancy test

Exclusion Criteria:

* History of complicated/obstructive diverticular disease
* 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
* History of gastroparesis
* 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.
* Presence of cardiac pacemaker or gastric electrical stimulator.
* 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
* History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia
* Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
* Subjects with pelvic floor dysfunction/defecatory disorder
* Participation in another clinical study within one month prior to screening.
* Women who are pregnant or lactating

Participant flow

Outcome results

• CSBM1- an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment (Primary), Count of participants, Participants: Active Comparator-Vibrating Mode 1 7; Active Comparator-Vibrating Mode 2 7; Sham Comparator 9
• CSBM2- an Increase of at Least Two Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment (Primary), Count of participants, Participants: Vibrant Active Mode 1 2; Vibrant Active Mode 2 4; Sham 6
• SBM 1- Success Rate, Defined as as an Increase From the Base Line of at Least One Weekly Spontaneous Bowel Movement (SBM) During at Least 6 of the 8 Weeks of Treatment. (Secondary), Count of participants, Participants: Vibrant Active Mode 1 8; Vibrant Active Mode 2 9; Sham 7

Adverse events

Time frame: For each patient, safety data was collected for 10 weeks of study participation.

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2018-01-10)

• Tal Malina, B.SC MBA, Study director, Vibrant Gastro