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Last Updated: May 25, 2025

CLINICAL TRIALS PROFILE FOR COLYTE


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All Clinical Trials for Colyte

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

Clinical Trial Conditions for Colyte

Condition Name

Condition Name for Colyte
Intervention Trials
Bowel Cleansing Efficacy 1
Bowel Preparation Before Colonoscopy 1
Bowel Preparation for Colonoscopy 1
Effectiveness of SMS to Fix PC Interval 1
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Condition MeSH

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

Trials by Country

Trials by Country for Colyte
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
Location Trials
New York 1
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Clinical Trial Progress for Colyte

Clinical Trial Phase

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

Clinical Trial Status for Colyte
Clinical Trial Phase Trials
Completed 6
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Clinical Trial Sponsors for Colyte

Sponsor Name

Sponsor Name for Colyte
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
Sponsor Trials
Other 5
U.S. Fed 2
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Clinical Trials, Market Analysis, and Projections for Colyte

Introduction to Colyte

Colyte, a bowel preparation solution, is commonly used for colonoscopy and other gastrointestinal procedures. It contains polyethylene glycol 3350 (PEG 3350) and various electrolytes to cleanse the bowel effectively. Here, we will delve into the current state of clinical trials, market analysis, and future projections related to Colyte.

Clinical Trials and Efficacy

While Colyte itself is not typically the subject of new clinical trials due to its established use, understanding the broader context of gastrointestinal treatments can provide insights.

Bowel Preparation Efficacy

Clinical studies on bowel preparation solutions like Colyte have shown high efficacy in cleansing the bowel prior to procedures such as colonoscopy. These studies highlight the importance of proper bowel preparation to ensure accurate diagnostic results and safe procedures[4].

Safety Profile

Colyte has a well-documented safety profile, with common adverse reactions including nausea, abdominal fullness, and bloating. However, it is contraindicated in certain conditions such as gastrointestinal obstruction, bowel perforation, and toxic colitis or megacolon[4].

Market Analysis

Current Market Trends

The market for bowel preparation solutions is part of the larger gastrointestinal (GI) health market. This market is influenced by several factors, including the prevalence of GI diseases and the demand for diagnostic procedures.

  • Prevalence of GI Diseases: The increasing prevalence of chronic GI diseases drives the demand for bowel preparation solutions. For instance, conditions like ulcerative colitis, which require frequent diagnostic procedures, contribute to the market growth[1][3].

  • Diagnostic Procedures: The number of colonoscopies and other GI procedures is on the rise, driven by early detection and preventive care initiatives. This trend supports the continued demand for effective bowel preparation solutions like Colyte[4].

Competitive Landscape

The market for bowel preparation solutions is competitive, with several products available. However, Colyte remains a popular choice due to its efficacy and safety profile.

  • Generic and Branded Products: The presence of generic alternatives to Colyte can impact market dynamics. However, branded products often maintain market share due to their established reputation and clinical evidence supporting their use[2].

Market Projections

Growth Expectations

The global market for clinical trials and GI health products is expected to grow significantly over the next few years.

  • Clinical Trials Market: The global clinical trials market is projected to grow from $61.58 billion in 2024 to $106.78 billion by 2032, at a CAGR of 7.1%. This growth is driven by the increasing number of clinical trials, particularly for chronic diseases[3].

  • GI Health Market: The GI health market, including bowel preparation solutions, is expected to benefit from advancements in science and technology. Innovations in diagnostic and therapeutic areas will continue to drive market growth[2].

Economic Outlook

The overall economic outlook also influences the market for healthcare products like Colyte.

  • GDP Growth: With estimated GDP growth rates of around 2.0% in the long term, the U.S. economy is expected to support steady growth in the healthcare sector. This economic stability is crucial for the continued investment in healthcare products and services[5].

Challenges and Opportunities

Pricing and Access

One of the significant challenges facing the life sciences industry, including the market for bowel preparation solutions, is pricing and access. Nearly half of the surveyed executives expect pricing and access issues to significantly impact their strategies in 2025[2].

Innovation and R&D

Companies are focusing on R&D to enhance their market positions. Innovations in bowel preparation solutions, such as more patient-friendly formulations or improved efficacy, could provide opportunities for growth[2].

Key Takeaways

  • Established Efficacy: Colyte has a well-established efficacy in bowel preparation for GI procedures.
  • Market Growth: The market for bowel preparation solutions is expected to grow, driven by the increasing prevalence of GI diseases and the demand for diagnostic procedures.
  • Economic Stability: The stable economic outlook supports continued investment in healthcare products.
  • Challenges: Pricing and access remain significant challenges for the life sciences industry.
  • Innovation: R&D initiatives are crucial for maintaining market competitiveness and driving growth.

FAQs

What is Colyte used for?

Colyte is used for bowel cleansing prior to colonoscopy or other gastrointestinal procedures.

What are the common adverse reactions to Colyte?

Common adverse reactions include nausea, abdominal fullness, and bloating. Less frequent reactions include abdominal cramps, vomiting, and anal irritation[4].

Is Colyte contraindicated in any conditions?

Yes, Colyte is contraindicated in conditions such as gastrointestinal obstruction, bowel perforation, gastric retention, ileus, toxic colitis or megacolon, and known allergy or hypersensitivity to any component of Colyte[4].

How does the economic outlook impact the market for Colyte?

A stable economic outlook with expected GDP growth supports continued investment in healthcare products, including bowel preparation solutions like Colyte[5].

What are the future projections for the market of bowel preparation solutions?

The market is expected to grow driven by the increasing prevalence of GI diseases and advancements in science and technology. However, challenges such as pricing and access need to be addressed[2][3].

Sources

  1. Louis, E., Schreiber, S., Panaccione, R., et al. (2024). Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA, 332(11), 881–897. doi: 10.1001/jama.2024.12414
  2. Deloitte Insights. (2024). 2025 life sciences outlook. Retrieved from https://www2.deloitte.com/us/en/insights/industry/health-care/life-sciences-and-health-care-industry-outlooks/2025-life-sciences-executive-outlook.html
  3. Fortune Business Insights. (n.d.). Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]. Retrieved from https://www.fortunebusinessinsights.com/clinical-trials-market-106930
  4. Meda Pharmaceuticals Inc. (2021). Colyte® with Flavor Packs (peg-3350 & electrolytes for oral solution). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018983s051lbl.pdf
  5. Silvercrest Group. (2024). Economic & Market Outlook—2025 & Beyond. Retrieved from https://www.silvercrestgroup.com/economic-market-outlook-2025-beyond/
Last updated: 2025-01-03

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