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

Study Overview
=================
Brief Summary
-----------------
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled pilot study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation. Three arms will be assessed: Vibrant Capsule with vibrating mode 1 administered 5 times per week Vibrant Capsule with vibrating mode 2 administered 5 times per week Sham Capsule administered 5 times per week 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.

Official Title
-----------------
A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Device: Vibrating Capsule
* Device: Sham capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrating Mode 1<br>Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week) | Device: Vibrating Capsule<br>* Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)<br>|
| Experimental: Vibrating Mode 2<br>Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week) | Device: Vibrating Capsule<br>* Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)<br>|
| Sham Comparator: Sham<br>Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week) | Device: Sham capsule<br>* Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Spontaneous Bowel Movement 1 success rate, and Complete Spontaneous Bowel Movement 2 success rate | Complete Spontaneous Bowel Movement 1 success rate is defined as an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement during at least 6 of the 8 weeks of treatment, and Complete Spontaneous Bowel Movement 2 success rate is defined as an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement during at least 6 of the 8 weeks of treatment. | 8 weeks |