DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Given Imaging Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: The preparation regimen (Other)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Given Imaging Ltd.

Official(s) and/or principal investigator(s):
PANKAJ K. KASHYAP, M.D., Principal Investigator, Affiliation: Pinnacle Research Group, LLC

Summary

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

Clinical Details

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: 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.

Detailed 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.

Eligibility

Minimum age: 50 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pinnacle Research Group, LLC, Anniston, Alabama 36207, United States
Additional Information

Given Imaging website

Pinnacle Research Group website

Starting date: March 2012
Last updated: July 4, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017