Safety & Efficacy of the Vibrant Capsule in Aiding Patients With Functional Constipation



Status:Not yet recruiting
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:7/13/2016
Start Date:July 2016
Contact:Lior Ben Tsur
Email:Lior.b@vibrantgastro.com
Phone:+972-46-663322

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A Prospective, Multicenter, Adaptive, Randomized, Double-blind, Sham-controlled Study to Assess the Safety and Efficacy of the Vibrant Capsule in Functional Constipation

The study is a prospective, multicenter, adaptive, randomized, double-blind, sham-controlled
study, to evaluate the safety and efficacy of the Vibrant Capsule vs. Sham Capsule in aiding
relieving constipated individuals.

The objectives are to assess the safety and efficacy of the Vibrant Capsule taken at a
frequency of administration of 5 capsules/week.

Two arms will be assessed:

- Vibrant Capsule administered 5 times/week

- Sham Capsule administered 5 times/week

The study will allow for up to two interim analyses.

Patients will follow a 2 weeks baseline period and then be randomized into one of the two
arms, for a treatment of 6 weeks. During the 2 weeks baseline, patients will be asked to
refrain from taking any medication or supplement they are using to relieve their
constipation. After 14 days the patients will re-visit the medical center for the baseline
visit. Eligibility will be re-assessed and eligible patients will be randomized into one of
the arms.

Patients will be instructed to complete a simple patient eDiary throughout the duration of
the study. After 6 weeks of treatment, treatment will be ceased and patients will visit the
medical center one last time for evaluation.


Inclusion Criteria:

1. Patients aged 18 years and older

2. Patients with Chronic Idiopathic Constipation 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)

3. Patients with an average of less than 3 Spontaneous Bowel Movements per week and at
least 1 Spontaneous Bowel Movement per week

4. Patients with an average of less than 1 Complete Spontaneous Bowel Movement per week

5. Normal colonoscopy performed within 10 years prior to study participation, unless the
patients are less than 50 years old and without alarm signs and/or symptoms

6. Patient signed the Informed Consent Form

7. Female subjects must have a negative urine pregnancy test 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 urine pregnancy test will not be necessary.

Exclusion Criteria:

1. History of complicated/obstructive diverticular disease

2. History of intestinal or colonic obstruction.

3. History of significant gastrointestinal disorder, including any form of inflammatory
bowel disease or gastrointestinal malignancy

4. Use of any of the following medications:

- Medications that may affect intestinal motility, prokinetics, anti-depressants,
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.

5. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic,
biliary, endocrine, psychiatric or neurologic disease.

6. Presence of cardiac pacemaker or gastric electrical stimulator.

7. History of, or current eating disorders, such as anorexia, bulimia, or compulsory
overeating.

8. Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically
significant rectocele, history of intestinal resection or evidence of any structural
abnormality of the gastrointestinal tract that might affect transit

9. History of Zenker's diverticulum, dysphagia or esophageal stricture

10. Chronic use of non-steroidal anti-inflammatory drugs: chronic use is defined as
taking full dose non-steroidal anti-inflammatory drugs more than three times a week
for at least six months. Patients on cardiac doses of aspirin may be enrolled in the
study

11. Patients with pelvic floor dysfunction/defecatory disorder, based on patient history

12. Participation in another clinical study within one month prior to screening.

13. Women who are pregnant or lactating

14. Inability to use an electronic daily Diary (on a computer, phone application, tablet
or other electronic device) to report symptoms and medication usage

15. Any other condition which in the opinion of the investigator may adversely affect the
safety of the patient or would limit the patient's ability to complete the study.
We found this trial at
5
sites
4800 Belfort Rd # 2
Jacksonville, Florida 32256
Principal Investigator: Kyle P Etzkorn, MD
Phone: 904-680-0871
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Anthony J Lembo, MD
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Albuquerque, New Mexico 87109
Principal Investigator: Paula J Lane, MD
Phone: 505-848-3773
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Houston, Texas 77030
Principal Investigator: Eamonn M Quigley, MD
Phone: 713-441-3245
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Salt Lake City, Utah 84132
Principal Investigator: Ashok K Tuteja, MD, MPH
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Salt Lake City, UT
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