CLINICAL TRIALS PROFILE FOR COLYTE
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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. |
| NCT01745835 ↗ | Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation | Completed | Seoul National University Hospital | Phase 3 | 2013-01-30 | comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy preparation. |
| NCT03315949 ↗ | Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose | Completed | Incheon St.Mary's Hospital | Phase 3 | 2017-05-01 | Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy, same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing for morning colonoscopy was validated. To date, there was no study which compared the bowel cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The aim of current study is to compare the bowel cleansing efficacy, adverse events, and patient's tolerability between the two group. Subjects who underwent colonoscopy for various reasons were included. After agreeing to participate in the study, study participants were randomly assigned to split dose or same day dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15 minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose group, bowel cleansing was started from 5AM for subjects who were scheduled to receive colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested 2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy. Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and laboratory tests were checked before colonoscopy. Study participants completed questionnaire which contained patient's satisfaction, tolerability, and adverse event during bowel cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared between the two groups. Successful bowel cleansing was estimated 85% for split dose group. The investigators set 10% for inferior margin. Considering 10% drop out, a total of 352 subjects will be recruited. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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