Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy
1 other identifier
interventional
25
1 country
1
Brief Summary
This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2 Capsule Endoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 11, 2012
CompletedFirst Posted
Study publicly available on registry
April 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 31, 2019
July 1, 2012
3 months
March 11, 2012
July 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (1)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
PANKAJ K. KASHYAP, M.D.
Pinnacle Research Group, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2012
First Posted
April 11, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
July 31, 2019
Record last verified: 2012-07