Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy

Study Overview
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Brief Summary
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This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2 Capsule Endoscopy.

Detailed Description
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The preparation regimen used for the PillCam® Colon 2 procedure consists of several colon cleansing materials. Different combinations of the above regimen were tested and evaluated for safety by monitoring of adverse events in multiple clinical studies, with more than 1000 subjects enrolled to date. No Serious Adverse Events related to the preparation were noted. In this study, each subject will be required to undergo serum chemistry tests (blood tests) at several time points to evaluate the safety of the regimen. No capsule ingestion is involved.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: The preparation regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between 50 - 75 years of age. Subject is healthy without any known disease, or any current symptoms of any disease or other abnormal condition. Subject received an explanation about the nature of the study and agrees to provide written informed consent. Subject has normal serum chemistry tests at baseline. Exclusion Criteria: Subject has any allergy or other known contraindication to the medications used in the study. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters. Subject has Type 1 or Type II Diabetes. Subject has any condition which precludes compliance with study instructions. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception. Subject suffers from life threatening conditions. Concurrent participation in another clinical trial using any investigational drug or device.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The preparation regimen|Regimen includes administration of 4 Senna tablets 2 days before the procedure, 2-liters of PEG on the evening before the procedure, 2-liters of PEG on the morning of the procedure, 10mg Metoclopramide, two boosts (6-oz and 3-oz) of SUPREP oral sulfate solution and a 10mg Bisacodyl suppository|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of a bowel preparation regimen comprised of Sulfate free Polyethylene glycol electrolyte lavage solution (SF-PEG) plus SUPREP oral sulfate solution as a booster, in adult subjects. | Safety will be evaluated by number of Adverse Events and percentage of subjects with clinically siginifcant change in serum chemistry test. | Latest blood test conducted (i.e. 24 hours after suppository or seven days after procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers