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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR COLYTE WITH FLAVOR PACKS


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All Clinical Trials for Colyte With Flavor Packs

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Colyte With Flavor Packs

Condition Name

Condition Name for Colyte With Flavor Packs
Intervention Trials
Bowel Preparation for Colonoscopy 1
Effectiveness of SMS to Fix PC Interval 1
Healthy Person 1
Spinal Cord Injury 1
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Condition MeSH

Condition MeSH for Colyte With Flavor Packs
Intervention Trials
Spinal Cord Injuries 1
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Clinical Trial Locations for Colyte With Flavor Packs

Trials by Country

Trials by Country for Colyte With Flavor Packs
Location Trials
Korea, Republic of 4
Canada 1
United States 1
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Trials by US State

Trials by US State for Colyte With Flavor Packs
Location Trials
New York 1
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Clinical Trial Progress for Colyte With Flavor Packs

Clinical Trial Phase

Clinical Trial Phase for Colyte With Flavor Packs
Clinical Trial Phase Trials
Phase 3 3
N/A 1
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Clinical Trial Status

Clinical Trial Status for Colyte With Flavor Packs
Clinical Trial Phase Trials
Completed 6
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Clinical Trial Sponsors for Colyte With Flavor Packs

Sponsor Name

Sponsor Name for Colyte With Flavor Packs
Sponsor Trials
Inje University 2
VA Office of Research and Development 1
University of Calgary 1
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Sponsor Type

Sponsor Type for Colyte With Flavor Packs
Sponsor Trials
Other 5
U.S. Fed 2
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Colyte with Flavor Packs: Clinical, Market, and Projection Analysis

Introduction

Colyte with Flavor Packs is a widely used bowel preparation solution, primarily indicated for cleansing the bowel before procedures such as colonoscopy or barium enema X-ray examinations. This article will delve into the clinical aspects, market analysis, and future projections of this drug.

Clinical Pharmacology and Mechanism

Colyte with Flavor Packs works by inducing diarrhea through the osmotic activity of polyethylene glycol 3350 (PEG-3350) combined with electrolytes. This solution is isosmotic, meaning it does not significantly alter the fluid and electrolyte balance in the body, allowing large volumes to be administered safely[2][4].

Indications and Usage

The primary indication for Colyte with Flavor Packs is bowel cleansing prior to colonoscopy or barium enema X-ray examinations. Patients are advised to fast for at least 3 hours before administration and to avoid solid foods for 2 hours before and after starting the treatment. Clear liquids can be consumed up until 2 hours before the procedure[2][4].

Dosage and Administration

The recommended adult oral dose is 240 mL (8 fl. oz.) every 10 minutes. The solution should be reconstituted with water to a total volume of 4 liters. Administration can be oral or via nasogastric tube at a rate of 20-30 mL per minute. The process is complete when the fecal discharge is clear, typically after consuming 3-4 liters of the solution[2][4].

Adverse Reactions

Common adverse reactions include nausea, abdominal fullness, bloating, abdominal cramps, and vomiting. These reactions are generally transient. Less frequently, patients may experience anal irritation, urticaria, rhinorrhea, dermatitis, and in rare cases, anaphylaxis or other severe allergic reactions[1][4].

Clinical Trials Update

There are no ongoing or recent clinical trials specifically focused on Colyte with Flavor Packs. The drug has been well-established and widely used for bowel preparation for many years, and its efficacy and safety profile are well-documented. However, continuous monitoring and post-marketing surveillance help in identifying any rare adverse events or long-term effects[1][2].

Market Analysis

Market Size and Share

The global market for drugs used for bowel preparation, which includes Colyte with Flavor Packs, was valued at approximately USD 1 billion in 2023. The polyethylene glycol (PEG) solutions segment, to which Colyte belongs, dominates the market due to its high efficacy, safety, and patient acceptability[5].

Regional Market

North America is the leading regional market, driven by the high prevalence of colorectal cancer and a well-established healthcare infrastructure. The Asia-Pacific region is expected to witness the highest growth rate, fueled by increasing awareness about gastrointestinal health and rising disposable incomes[5].

Distribution Channels

Hospital pharmacies hold the largest market share due to the high volume of colonoscopy procedures performed in hospital settings. This indicates that Colyte with Flavor Packs is predominantly used in clinical settings where thorough bowel preparation is crucial[5].

Market Projections

Growth Rate

The bowel preparation market is projected to grow significantly, driven by increasing demand for colonoscopy procedures and other diagnostic tests that require thorough bowel cleansing. The Asia-Pacific region is expected to contribute substantially to this growth due to its expanding healthcare sector and increasing awareness of gastrointestinal health[5].

Competitive Landscape

Colyte with Flavor Packs competes with other PEG-based solutions and other types of bowel preparation drugs. However, its established brand and user-friendly flavor packs give it a competitive edge in terms of patient acceptability and compliance[2][5].

Key Takeaways

  • Clinical Efficacy: Colyte with Flavor Packs is highly effective in cleansing the bowel without significant alterations in fluid and electrolyte balance.
  • Market Dominance: The PEG solutions segment, including Colyte, dominates the bowel preparation market due to its safety and efficacy.
  • Regional Growth: North America leads the market, while the Asia-Pacific region is expected to show the highest growth rate.
  • Distribution: Hospital pharmacies are the primary distribution channels for Colyte with Flavor Packs.
  • Future Projections: The market is expected to grow significantly, driven by increasing demand for colonoscopy procedures and awareness of gastrointestinal health.

FAQs

What is the primary indication for Colyte with Flavor Packs?

Colyte with Flavor Packs is primarily indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examinations[2][4].

How is Colyte with Flavor Packs administered?

It can be administered orally or via nasogastric tube. The recommended dose is 240 mL (8 fl. oz.) every 10 minutes, with the solution reconstituted to a total volume of 4 liters[2][4].

What are the common adverse reactions to Colyte with Flavor Packs?

Common adverse reactions include nausea, abdominal fullness, bloating, abdominal cramps, and vomiting. These reactions are generally transient[1][4].

What is the market size and growth projection for bowel preparation drugs?

The global market for bowel preparation drugs was valued at approximately USD 1 billion in 2023 and is projected to grow significantly, with the Asia-Pacific region expected to show the highest growth rate[5].

Why does the PEG solutions segment dominate the bowel preparation market?

The PEG solutions segment dominates due to its high efficacy, safety, and patient acceptability[5].

Sources

  1. Colyte® with Flavor Packs (peg-3350 & electrolytes for oral solution) Prescribing Information. Colonoscopy Assist.
  2. Colyte with Flavor Packs: Package Insert / Prescribing Info. Drugs.com.
  3. Three promising drugs for treating Alzheimer's disease bring fresh hope. Alzheimer's Society.
  4. Colyte with Flavor Packs Advanced Patient Information. Drugs.com.
  5. Drugs Used For Bowel Preparation Market Size, Share, Growth. Data Horizon Research.

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