CLINICAL TRIALS PROFILE FOR POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

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.

Clinical Trial Conditions for Polyethylene Glycol 3350 And Electrolytes

Condition Name

Condition Name for Polyethylene Glycol 3350 And Electrolytes
Intervention	Trials
Constipation	3
Bowel Preparation	2
COVID-19 Pneumonia	1
Covid19	1

Condition MeSH

Condition MeSH for Polyethylene Glycol 3350 And Electrolytes
Intervention	Trials
Constipation	3
Colitis	1
Clostridium Infections	1
Colonic Neoplasms	1

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
France	1
Netherlands	1
China	1
Czechia	1

Trials by US State

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

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	4
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Polyethylene Glycol 3350 And Electrolytes
Clinical Trial Phase	Trials
Completed	7
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for Polyethylene Glycol 3350 And Electrolytes

Sponsor Name

Sponsor Name for Polyethylene Glycol 3350 And Electrolytes
Sponsor	Trials
Genesys Regional Medical Center	1
Medical College of Wisconsin	1
Tecnoquimicas S.A	1

Sponsor Type

Sponsor Type for Polyethylene Glycol 3350 And Electrolytes
Sponsor	Trials
Other	8
Industry	5

Polyethylene Glycol 3350 and Electrolytes: Clinical Trials, Market Analysis, and Projections

Introduction

Polyethylene glycol 3350 (PEG 3350) combined with electrolytes is a widely used treatment for constipation, including constipation associated with irritable bowel syndrome (IBS-C). This article delves into the clinical trials, market analysis, and future projections of this medication.

Clinical Trials Overview

Efficacy and Safety

A randomized clinical trial compared the efficacy and safety of PEG 3350 plus electrolytes (PEG 3350+E) against a placebo in adult patients with IBS-C. The trial showed that PEG 3350+E was superior to the placebo in relieving constipation, with a significant increase in the mean number of spontaneous bowel movements (SBMs) per day. The treatment also reduced abdominal discomfort and pain, although this reduction was not significantly different from the placebo group[1].

Dose-Finding Trials

Another clinical trial, an open-label, dose-finding study, evaluated the effectiveness of different doses of PEG 3350+E for treating constipation. The trial aimed to determine the proportion of subjects who had a bowel movement without straining or hard/lumpy stool within the first 24 hours of treatment. Secondary objectives included assessing relief from gas, bloating, and abdominal discomfort/cramping. This study helped in identifying optimal dosages for effective treatment[5].

Market Analysis

Global Market Size and Growth

The global polyethylene glycol market, which includes PEG 3350, was valued at USD 4,678.7 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 6.0% from 2023 to 2030. This growth is driven by the increasing demand for PEG in various industries, including pharmaceuticals, due to its non-toxicity, wear resistance, and solubility in organic solvents[2].

PEG 3350 Market Specifics

The global PEG 3350 market is projected to reach USD 3.09 billion by 2032, growing at a CAGR of 6.29% during the forecast period from 2023 to 2032. The market is segmented by product type, with the powder segment holding the largest market share of approximately 62.84% in 2022. This dominance is attributed to growing sedentary lifestyles, physical inactivity, and the rising prevalence of colorectal cancer[3].

Regional Market Dynamics

The Asia-Pacific region is the fastest-growing market for PEG 3350, driven by the rising geriatric population, adoption of sedentary lifestyles, and increasing prevalence of colorectal cancer. North America also shows significant growth, fueled by the rising prevalence of diseases such as diabetes, cancer, and neurological disorders[3].

Market Trends and Drivers

Increasing Demand in Pharmaceutical Sector

The pharmaceutical industry's growth, particularly in emerging markets like China, India, and Brazil, is a significant driver for the PEG 3350 market. The increasing expenditure on technology advancement and the rising importance of PEG as a lubricating solution in pharmaceutical formulations contribute to this growth[2].

Product Innovations

Continuous innovations in the form of new product launches, especially in the powder segment, are expected to drive market growth. Companies like Teva Pharmaceutical Industries Ltd, LGM Pharma, and McKesson Corporation are key players in this market, contributing to its expansion through product development and distribution[3].

Prescription and Over-the-Counter Trends

Sales and Prescription Data

Sales data from the U.S. market indicate that while prescription polyethylene glycol 3350 products decreased by 46% from 2007 to 2011, over-the-counter (OTC) products increased by 124% during the same period. In 2011, OTC products accounted for 37% of the total market, with MiraLAX and its generic equivalents being the most prescribed[4].

Pediatric Use

In the pediatric population, polyethylene glycol 3350 products are widely used, with approximately 13% of prescriptions (12.9 million out of 102 million) being dispensed to this age group from 2002 to 2011. MiraLAX and its generic equivalents dominate this segment, highlighting the drug's safety and efficacy in pediatric care[4].

Adverse Events and Safety Profile

Common Adverse Events

Clinical trials have identified abdominal pain and diarrhea as the most common drug-related adverse events associated with PEG 3350+E treatment. These events occur in a small percentage of patients, with abdominal pain reported in 4.5% of the PEG 3350+E group and diarrhea in 4.5% of both the PEG 3350+E and placebo groups[1].

Future Projections

Market Growth

The PEG 3350 market is expected to continue its growth trajectory, driven by increasing demand in developing economies and the expanding pharmaceutical sector. The Asia-Pacific region is anticipated to remain a key growth area due to its large and aging population, as well as the rising prevalence of lifestyle-related diseases[3].

Technological Advancements

Advancements in healthcare technology and the development of new formulations are likely to further boost the market. The integration of PEG 3350 into various healthcare products, including bowel preparation kits and other gastrointestinal treatments, will also contribute to market expansion[2].

Key Takeaways

• Clinical Efficacy: PEG 3350+E is superior to placebo in treating constipation and IBS-C, with significant improvements in bowel movements and abdominal discomfort.
• Market Growth: The global PEG 3350 market is projected to reach USD 3.09 billion by 2032, growing at a CAGR of 6.29%.
• Regional Dynamics: The Asia-Pacific region is the fastest-growing market, driven by demographic and lifestyle factors.
• Product Innovations: Continuous innovations, especially in the powder segment, drive market growth.
• Safety Profile: Common adverse events include abdominal pain and diarrhea, but the drug is generally safe and effective.

FAQs

What is the primary use of Polyethylene Glycol 3350 and Electrolytes?

Polyethylene Glycol 3350 and Electrolytes are primarily used to treat constipation, including constipation associated with irritable bowel syndrome (IBS-C).

What are the key findings from clinical trials on PEG 3350+E?

Clinical trials have shown that PEG 3350+E is superior to placebo in increasing spontaneous bowel movements and reducing abdominal discomfort and pain in patients with IBS-C[1].

How is the global PEG 3350 market expected to grow?

The global PEG 3350 market is expected to reach USD 3.09 billion by 2032, growing at a CAGR of 6.29% during the forecast period from 2023 to 2032[3].

Which region dominates the PEG 3350 market?

The Asia-Pacific region dominates the PEG 3350 market, driven by the rising geriatric population, sedentary lifestyles, and increasing prevalence of colorectal cancer[3].

What are the common adverse events associated with PEG 3350+E treatment?

The most common drug-related adverse events are abdominal pain and diarrhea, occurring in a small percentage of patients[1].

Sources

1. Randomized clinical trial: macrogol/PEG 3350 plus electrolytes for ... - PubMed
2. Polyethylene Glycol Market Size And Share Report, 2030 - Grand View Research
3. PEG 3350 Market Trends, Growth, Forecast 2032 - Market Research Future
4. 203595Orig1s000 - accessdata.fda.gov - FDA
5. Constipation | Study 18129 | Bayer - Clinical Trials Explorer - Bayer Clinical Trials Explorer