CLINICAL TRIALS PROFILE FOR COLYTE

All Clinical Trials for COLYTE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00856440 ↗	Safety and Efficacy of Routine Colonoscopy Preparations	Completed	US Department of Veterans Affairs		2006-06-01	Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. As currently performed, however, colonoscopy requires that stool be eliminated from the colon before the examination. If stool remains in the colon, visualization of the bowel will be partially or completely impaired and limits the effectiveness of the screening. A number of methods are employed for purging the bowel of waste material but they generally involve either administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches is uniformly effective in all individuals and neither is without potential complications, especially on the kidneys. It is the intent of the proposed research to study the relative efficacy and safety of these preparations in both able-bodied individuals as well as people with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a laxative or a combination of the two prior to a routine, clinically indicated colonoscopy. The quality of the preparation will be directly assessed during the colonoscopy and the effect of these preparations on kidney function will be determined. We suspect that when it comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research should allow us to determine which form of preparation is least harmful while achieving optimal effectiveness.
NCT00856440 ↗	Safety and Efficacy of Routine Colonoscopy Preparations	Completed	VA Office of Research and Development		2006-06-01	Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. As currently performed, however, colonoscopy requires that stool be eliminated from the colon before the examination. If stool remains in the colon, visualization of the bowel will be partially or completely impaired and limits the effectiveness of the screening. A number of methods are employed for purging the bowel of waste material but they generally involve either administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches is uniformly effective in all individuals and neither is without potential complications, especially on the kidneys. It is the intent of the proposed research to study the relative efficacy and safety of these preparations in both able-bodied individuals as well as people with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a laxative or a combination of the two prior to a routine, clinically indicated colonoscopy. The quality of the preparation will be directly assessed during the colonoscopy and the effect of these preparations on kidney function will be determined. We suspect that when it comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research should allow us to determine which form of preparation is least harmful while achieving optimal effectiveness.
NCT01286961 ↗	The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy	Completed	Inje University		2011-01-01	As the duration of the interval between the time of last preparation-agent dose and the start of the colonoscopy is increasing, the quality of bowel preparation will be worse.
NCT01415687 ↗	Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose	Completed	University of Calgary	Phase 3	2011-05-01	The objective of this study is to compare the efficacy, safety and tolerability of two bowel preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax plus Bisacodyl - with a specific emphasis on the right colon cleanliness. The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.
NCT01675739 ↗	Effectiveness of Fixed PC Interval Using SMS for Afternoon Colonoscopy	Completed	Inje University	N/A	2011-10-01	The purpose of this study is to evaluate the effectiveness of SMS (short message service of mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.

Clinical Trial Conditions for COLYTE

Condition Name

Condition Name for COLYTE
Intervention	Trials
The Timing of Bowel Preparation in Outpatient Colonoscopy	1
Unrecognized Condition	1
Bowel Cleansing Efficacy	1
Bowel Preparation Before Colonoscopy	1

Condition MeSH

Condition MeSH for COLYTE
Intervention	Trials
Spinal Cord Injuries	1

Clinical Trial Locations for COLYTE

Trials by Country

Trials by Country for COLYTE
Location	Trials
Korea, Republic of	4
United States	1
Canada	1

Trials by US State

Trials by US State for COLYTE
Location	Trials
New York	1

Clinical Trial Progress for COLYTE

Clinical Trial Phase

Clinical Trial Phase for COLYTE
Clinical Trial Phase	Trials
Phase 3	3
N/A	1

Clinical Trial Status

Clinical Trial Status for COLYTE
Clinical Trial Phase	Trials
Completed	6

Clinical Trial Sponsors for COLYTE

Sponsor Name

Sponsor Name for COLYTE
Sponsor	Trials
Inje University	2
University of Calgary	1
Seoul National University Hospital	1

Sponsor Type

Sponsor Type for COLYTE
Sponsor	Trials
Other	5
U.S. Fed	2