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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE


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505(b)(2) Clinical Trials for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT01077076 ↗ Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED) Completed Bayer Phase 3 2008-12-01 This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
OTC NCT04651088 ↗ Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet Not yet recruiting University of Texas Southwestern Medical Center Early Phase 1 2021-12-01 The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00045799 ↗ Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill Completed Bausch Health Americas, Inc. Phase 3 2002-05-01 Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗ Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill Completed Valeant Pharmaceuticals International, Inc. Phase 3 2002-05-01 Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00130598 ↗ PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION Completed Swiss National Science Foundation Phase 2/Phase 3 2005-06-01 Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00130598 ↗ PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION Completed University Hospital, Basel, Switzerland Phase 2/Phase 3 2005-06-01 Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00142272 ↗ Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial Completed Bayer Phase 3 2001-05-01 The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Condition Name

Condition Name for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Intervention Trials
Metabolic Acidosis 16
Acute Kidney Injury 16
Contrast Induced Nephropathy 15
Chronic Kidney Disease 14
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Condition MeSH

Condition MeSH for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Intervention Trials
Kidney Diseases 48
Acute Kidney Injury 30
Renal Insufficiency, Chronic 23
Renal Insufficiency 20
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Clinical Trial Locations for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Trials by Country

Trials by Country for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Location Trials
United States 196
Italy 19
Brazil 14
Canada 13
Australia 13
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Trials by US State

Trials by US State for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Location Trials
California 13
Texas 13
Florida 11
Pennsylvania 11
North Carolina 11
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Clinical Trial Progress for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Clinical Trial Phase Trials
Phase 4 72
Phase 3 40
Phase 2/Phase 3 14
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Clinical Trial Status

Clinical Trial Status for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Clinical Trial Phase Trials
Completed 138
Recruiting 31
Unknown status 30
[disabled in preview] 47
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Clinical Trial Sponsors for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Sponsor Name

Sponsor Name for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Sponsor Trials
University of Colorado, Denver 5
Bausch Health Americas, Inc. 5
Valeant Pharmaceuticals International, Inc. 5
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Sponsor Type

Sponsor Type for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Sponsor Trials
Other 316
Industry 66
NIH 12
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PEG-3350, Potassium Chloride, Sodium Bicarbonate, and Sodium Chloride: Clinical Trials, Market Analysis, and Projections

Introduction

Polyethylene glycol 3350 (PEG 3350) combined with electrolytes such as potassium chloride, sodium bicarbonate, and sodium chloride is a widely used formulation for treating constipation and preparing patients for colonoscopy. This article delves into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Efficacy in Constipation Associated with Irritable Bowel Syndrome (IBS-C)

A randomized clinical trial compared the efficacy and safety of PEG 3350 plus electrolytes (PEG 3350+E) versus placebo in adult patients with IBS-C. The study found that PEG 3350+E was superior to 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/pain, although this reduction was not significantly different from the placebo group[1].

Bowel Cleansing Prior to Colonoscopy

Clinical trials have also evaluated the efficacy of PEG 3350 with electrolytes for bowel cleansing before colonoscopy. These studies have shown that the solution effectively cleanses the bowel, usually within four hours, without significant changes in fluid or electrolyte balance. The solution is isosmotic, containing PEG 3350, sodium chloride, potassium chloride, and sodium bicarbonate, which helps in maintaining electrolyte balance[2][5].

Acceptability and Flavor Studies

A phase 4 study focused on the acceptability of a new flavor system with increasing levels of mannitol for PEG 3350 in subjects with infrequent bowel movements. This open-label, parallel-arm study aimed to evaluate the taste of various preparations using a rating scale, indicating ongoing efforts to improve patient compliance through better flavor options[4].

Market Analysis

Current Market Position

PEG 3350 with electrolytes is a well-established treatment for constipation and bowel cleansing. It is widely prescribed due to its efficacy and safety profile. The market for laxatives and bowel preparation solutions is competitive, but PEG 3350 with electrolytes holds a significant share due to its broad indications and favorable clinical outcomes.

Market Trends

The demand for effective and safe laxatives and bowel preparation solutions continues to grow, driven by increasing awareness of gastrointestinal health and the need for thorough bowel cleansing before diagnostic procedures like colonoscopy. The market is also influenced by advancements in formulation and flavor options, which enhance patient compliance.

Competitive Landscape

The market for bowel preparation solutions includes other products like SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) and MoviPrep (polyethylene glycol, sodium ascorbate, sodium sulfate). However, PEG 3350 with electrolytes remains a preferred choice due to its established efficacy and safety profile, as well as its isosmotic nature which minimizes electrolyte imbalances[3].

Projections and Future Outlook

Growing Demand

The demand for PEG 3350 with electrolytes is expected to grow, driven by an aging population and increasing rates of gastrointestinal disorders. The need for effective bowel preparation solutions before colonoscopy will continue to drive the market, especially as screening recommendations become more widespread.

Innovations in Formulation

Future innovations in flavor systems and formulation are likely to enhance patient compliance. Studies like the one on mannitol flavor systems indicate a focus on improving the taste and acceptability of the solution, which could further boost market share[4].

Regulatory Environment

The regulatory environment is supportive, with approvals and clear guidelines from regulatory bodies like the FDA. The safety and efficacy of PEG 3350 with electrolytes are well-documented, which helps in maintaining a strong market position[2][5].

Safety and Adverse Events

Common Adverse Events

Clinical trials have identified common adverse events associated with PEG 3350 with electrolytes, including abdominal pain and diarrhea. However, these events are generally mild and transient. The solution is well-tolerated, and serious adverse events are rare[1][2].

Special Considerations

In pediatric patients, especially those under 2 years of age, careful monitoring is recommended due to the risk of hypoglycemia and electrolyte imbalances. However, the overall safety profile supports its use in pediatric patients aged 6 months and older[5].

Key Takeaways

  • Efficacy in IBS-C: PEG 3350 with electrolytes is superior to placebo in relieving constipation associated with IBS-C.
  • Bowel Cleansing: The solution is effective for bowel cleansing prior to colonoscopy, maintaining electrolyte balance.
  • Market Position: It holds a significant market share due to its broad indications and favorable clinical outcomes.
  • Future Outlook: Growing demand driven by an aging population and innovations in formulation.
  • Safety: Generally well-tolerated with mild and transient adverse events.

FAQs

Q: What is the primary use of PEG 3350 with electrolytes?

A: The primary uses are for treating constipation, including constipation associated with irritable bowel syndrome (IBS-C), and for bowel cleansing prior to colonoscopy.

Q: How does PEG 3350 with electrolytes work?

A: It works as an osmotic laxative, drawing water into the bowel to soften and bulk the stool, and the electrolytes help maintain fluid and electrolyte balance.

Q: What are the common adverse events associated with PEG 3350 with electrolytes?

A: Common adverse events include abdominal pain and diarrhea, which are generally mild and transient.

Q: Can PEG 3350 with electrolytes be used in pediatric patients?

A: Yes, it can be used in pediatric patients aged 6 months and older, but careful monitoring is recommended, especially in those under 2 years of age.

Q: What innovations are being explored to improve the use of PEG 3350 with electrolytes?

A: Innovations in flavor systems, such as the use of mannitol, are being explored to improve patient compliance.

Sources

  1. Chapman RW., Stanghellini V., Geraint M., Halphen M. - Randomized clinical trial: macrogol/PEG 3350 plus electrolytes for treatment of patients with constipation associated with irritable bowel syndrome.
  2. DailyMed - PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution.
  3. FDA - 213135Orig1s000 - SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets.
  4. Bayer Clinical Trials Explorer - Study to gather information on the acceptability of a new flavor system with increasing levels of 2, 4, 6 g or higher of Mannitol for PEG 3350.
  5. Drugs.com - PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution.

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