CLINICAL TRIALS PROFILE FOR POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
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All Clinical Trials for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00603681 ↗ | Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation | Completed | Orion Corporation, Orion Pharma | Phase 4 | 2008-01-01 | The aim of the study is to show that new polyethylene glycol (PEG) solution without electrolytes is as effective in the treatment of constipation as PEG solution with electrolytes in the elderly institutionalized people. Also, the tolerability and the safety of the study drug will be examined. |
| NCT01170754 ↗ | Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy | Completed | Temple University | Phase 4 | 2010-04-01 | A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets Phosphosoda) are now used on a limited basis because of their known association with renal injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely) has been used for over two decades for colon cleansing. The mixture is not very palatable due to the electrolyte additives which include sodium sulfate. To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of Gatorade. Conservatively, we estimate that 25% of colonoscopies in the US are being done with this prep. Anecdotally there have been reports (case series) that it is far more palatable and the prep is equally efficacious. The active ingredient, PEG, is not changed and therefore this is not surprising. The issue at present is that there has never been a blinded study to confirm these claims. This study will compare the efficacy of the two preps. There is no funding. The investigators will charge insurance companies for the prep - this is our current practice. The procedures will be done on healthy individuals referred for colon cancer screening and the exam will be billed to their insurance. There will be no patient honorarium. The investigators will check electrolytes to be sure patients do not develop hypokalemia with the Gatorade prep. |
| NCT01212445 ↗ | Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515) | Completed | Bayer | Phase 2 | 2010-10-01 | The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping. In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM. |
| NCT01251822 ↗ | Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation | Completed | Norgine | Phase 3 | 2010-11-01 | This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that of prucalopride in the treatment of chronic constipation in females. A total of 240 patients will be randomly allocated to treatment with one or the other agent. The study consists of a 14-day run-in period, with treatment subsequently administered for 28 days on a daily basis. During the study, patients will fill in a stool diary, samples of faeces will be collected, and colonic transit time will be measured prior to therapy, and from days 22 to 28 of treatment. The proportion of patients with normalised bowel movements (three or more spontaneous movements) during the last week of the study (days 22 to 28 of treatment) will be compared between treatments. |
| NCT01630096 ↗ | Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe | Unknown status | Ascension Genesys Hospital | Phase 4 | 2012-06-01 | Once the lab test is positive for c. diff, the investigators will order the patient to have PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not clear 2 more liters may be ordered. At enrollment, the treatment arm will have an order for 500 cc Normal saline to be given I.V. The patient will continue with antibiotic treatment as well. The investigators will plan to check c. diff tests daily to see when they become negative. The investigators will perform chart audit/review to track mortality, the length of stay, ICU days, surgical intervention, and APACHE scores (assessment of disease severity). Chart audit will be used to collect data on their diet and how they feel using a visual analog scale (collected by nursing staff daily as a standard procedure; see attached pain scale). Using chart audit, the investigators will record whether the patient is immunocompromised or not. |
| NCT01630096 ↗ | Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe | Unknown status | Genesys Regional Medical Center | Phase 4 | 2012-06-01 | Once the lab test is positive for c. diff, the investigators will order the patient to have PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not clear 2 more liters may be ordered. At enrollment, the treatment arm will have an order for 500 cc Normal saline to be given I.V. The patient will continue with antibiotic treatment as well. The investigators will plan to check c. diff tests daily to see when they become negative. The investigators will perform chart audit/review to track mortality, the length of stay, ICU days, surgical intervention, and APACHE scores (assessment of disease severity). Chart audit will be used to collect data on their diet and how they feel using a visual analog scale (collected by nursing staff daily as a standard procedure; see attached pain scale). Using chart audit, the investigators will record whether the patient is immunocompromised or not. |
| NCT02124447 ↗ | Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy | Withdrawn | Medical College of Wisconsin | N/A | 2014-06-01 | This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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