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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575093
• Other study ID #: MA-112
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subject is between 50 - 75 years of age.

2. Subject is healthy without any known disease, or any current symptoms of any disease or other abnormal condition.

3. Subject received an explanation about the nature of the study and agrees to provide written informed consent.

4. Subject has normal serum chemistry tests at baseline.

Exclusion Criteria:

1. Subject has any allergy or other known contraindication to the medications used in the study.

2. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.

3. Subject has Type 1 or Type II Diabetes.

4. Subject has any condition which precludes compliance with study instructions.

5. 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.

6. Subject suffers from life threatening conditions.

7. Concurrent participation in another clinical trial using any investigational drug or device.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Pinnacle Research Group, LLC	Anniston	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)

External Links

•   Given Imaging website
•   Pinnacle Research Group website