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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

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Clinical Trials for Polyethylene Glycol 3350 And Electrolytes

Trial ID Title Status Sponsor Phase Summary
NCT00603681 Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation Completed Orion Corporation, Orion Pharma Phase 4 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Polyethylene Glycol 3350 And Electrolytes

Condition Name

Condition Name for Polyethylene Glycol 3350 And Electrolytes
Intervention Trials
Constipation 3
Patients Undergoing Screening or Surveillance Colonoscopy 1
Digestive System Disease 1
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Condition MeSH

Condition MeSH for Polyethylene Glycol 3350 And Electrolytes
Intervention Trials
Constipation 3
Gastrointestinal Diseases 1
Digestive System Diseases 1
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Clinical Trial Locations for Polyethylene Glycol 3350 And Electrolytes

Trials by Country

Trials by Country for Polyethylene Glycol 3350 And Electrolytes
Location Trials
United States 3
Romania 1
Ireland 1
France 1
Finland 1
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Trials by US State

Trials by US State for Polyethylene Glycol 3350 And Electrolytes
Location Trials
Michigan 1
Pennsylvania 1
Wisconsin 1
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Clinical Trial Progress for Polyethylene Glycol 3350 And Electrolytes

Clinical Trial Phase

Clinical Trial Phase for Polyethylene Glycol 3350 And Electrolytes
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Polyethylene Glycol 3350 And Electrolytes
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 2
Unknown status 1
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Clinical Trial Sponsors for Polyethylene Glycol 3350 And Electrolytes

Sponsor Name

Sponsor Name for Polyethylene Glycol 3350 And Electrolytes
Sponsor Trials
Orion Corporation, Orion Pharma 1
Tecnoquimicas S.A 1
Medical College of Wisconsin 1
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Sponsor Type

Sponsor Type for Polyethylene Glycol 3350 And Electrolytes
Sponsor Trials
Other 5
Industry 4
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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
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Fuji
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