Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy
|ClinicalTrials.gov Identifier: NCT01575093|
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Other: The preparation regimen||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
- 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
- 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. [ Time Frame: Latest blood test conducted (i.e. 24 hours after suppository or seven days after procedure) ]Safety will be evaluated by number of Adverse Events and percentage of subjects with clinically siginifcant change in serum chemistry test.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575093
|United States, Alabama|
|Pinnacle Research Group, LLC|
|Anniston, Alabama, United States, 36207|
|Principal Investigator:||PANKAJ K. KASHYAP, M.D.||Pinnacle Research Group, LLC|