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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR NULYTELY


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All Clinical Trials for Nulytely

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00164151 ↗ A Comparison of the Efficacy and Safety of HalfLytely Vs Visicol Prior To Colonoscopy. Completed Braintree Laboratories Phase 3 2001-06-01 The objective of this study is to determine the efficacy and safety of HalfLytely as compared to Visicol as bowel preparations before colonoscopic examination.
NCT00164164 ↗ HalfLytely Bowel Prep System for Colonoscopy Completed Braintree Laboratories Phase 3 1999-08-01 The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.
NCT00425594 ↗ A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population Completed Braintree Laboratories Phase 4 2007-01-01 This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.
NCT00689026 ↗ Efficacy of Lubiprostone in Combination With Standard PEG Preparation Terminated Takeda Pharmaceuticals North America, Inc. N/A 2008-05-01 A large population-based study has shown diabetes to be an independent risk factor for colon cancer compared to the general population. Thus, the completion of an adequately prepped colonoscopy is requisite in providing diabetics with adequate colon cancer screening. Recent data has shown that diabetic patients have poorer response to bowel cleansing compared to non-diabetics (with a standard PEG prep, only 62% of diabetic patients had their colonoscopy preps rated as good or better vs. 97% of normal patients, p<0.001). This may be due to the fact that a majority of diabetic patients report constipation as a common gastrointestinal complaint. We postulate that lubiprostone (Amitiza), in combination with PEG, will have additional efficacy over standard PEG preparation, and provide optimal safe and effective colonic cleansing for diabetics.
NCT00689026 ↗ Efficacy of Lubiprostone in Combination With Standard PEG Preparation Terminated Augusta University N/A 2008-05-01 A large population-based study has shown diabetes to be an independent risk factor for colon cancer compared to the general population. Thus, the completion of an adequately prepped colonoscopy is requisite in providing diabetics with adequate colon cancer screening. Recent data has shown that diabetic patients have poorer response to bowel cleansing compared to non-diabetics (with a standard PEG prep, only 62% of diabetic patients had their colonoscopy preps rated as good or better vs. 97% of normal patients, p<0.001). This may be due to the fact that a majority of diabetic patients report constipation as a common gastrointestinal complaint. We postulate that lubiprostone (Amitiza), in combination with PEG, will have additional efficacy over standard PEG preparation, and provide optimal safe and effective colonic cleansing for diabetics.
NCT00953043 ↗ Lubiprostone, Colonic Motility and Sensation Completed National Center for Research Resources (NCRR) Phase 4 2007-09-01 This study is being done to evaluate the effects of lubiprostone, a drug approved and used for constipation, on pattern of contractions of the colon and the colon's sensitivity to distension.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nulytely

Condition Name

Condition Name for Nulytely
Intervention Trials
Colonoscopy 4
Preparation for Colonoscopy 2
Bowel Preparation 1
Bowel Preparation for Colonoscopy 1
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Condition MeSH

Condition MeSH for Nulytely
Intervention Trials
Diabetes Mellitus, Type 1 1
Diabetes Mellitus 1
Diabetes Mellitus, Type 2 1
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Clinical Trial Locations for Nulytely

Trials by Country

Trials by Country for Nulytely
Location Trials
United States 30
Mexico 1
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Trials by US State

Trials by US State for Nulytely
Location Trials
Texas 3
Illinois 3
Massachusetts 2
Minnesota 2
Indiana 2
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Clinical Trial Progress for Nulytely

Clinical Trial Phase

Clinical Trial Phase for Nulytely
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Nulytely
Clinical Trial Phase Trials
Completed 8
Terminated 1
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Clinical Trial Sponsors for Nulytely

Sponsor Name

Sponsor Name for Nulytely
Sponsor Trials
Braintree Laboratories 3
Gastroenterology Services, Ltd. 2
ColonaryConcepts LLC 1
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Sponsor Type

Sponsor Type for Nulytely
Sponsor Trials
Industry 6
Other 5
NIH 2
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Clinical Trials, Market Analysis, and Projections for NuLytely

Introduction to NuLytely

NuLytely is a bowel preparation solution commonly used before colonoscopy procedures. It is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes such as sodium chloride, sodium bicarbonate, and potassium chloride. Here, we will delve into the clinical trials, market analysis, and future projections for NuLytely.

Clinical Trials and Efficacy

Purpose and Design

Clinical trials for NuLytely have been conducted to evaluate its safety and efficacy. For example, a Phase 3 trial compared the safety and efficacy of HalfLytely (a variant of NuLytely with added bisacodyl) to NuLytely alone for bowel preparation prior to colonoscopy. This study aimed to determine which formulation was more effective and safer for patients[1].

Safety and Efficacy Findings

The safety and effectiveness of NuLytely have been supported by adequate and well-controlled clinical trials. These trials have shown that NuLytely is effective in preparing the bowel for colonoscopy, with the solution inducing watery stool that is clear and free of solid matter within a few hours of administration. However, common adverse reactions include nausea, abdominal fullness, bloating, abdominal cramps, vomiting, and anal irritation, which are generally transient and resolve quickly[2][4].

Special Populations

Clinical trials have also evaluated the use of NuLytely in pediatric and geriatric populations. For pediatric patients aged 6 months and older, the safety and efficacy are supported by evidence from clinical trials. However, use in children younger than 2 years requires careful monitoring for hypoglycemia and electrolyte imbalances. In geriatric patients, there is no significant difference in response compared to younger patients, although clinical studies did not include a large number of subjects aged 65 and over[2][4].

Market Analysis

Current Market Size

The clinical trials market, which includes bowel preparation solutions like NuLytely, is substantial and growing. The global clinical trials market was valued at $57.37 billion in 2023 and is expected to reach $90.59 billion by 2033, with a CAGR of 4.67% from 2024 to 2033. The U.S. market alone was valued at $27.81 billion in 2023 and is projected to hit $39.24 billion by 2033[3].

Regional Dominance

The clinical trials market is dominated by North America, particularly the United States, due to its advanced healthcare infrastructure and high prevalence of chronic disorders. The Asia-Pacific region is also emerging as a significant hub for clinical trials, with a notable increase in early-phase trials and a leading role in cell and gene therapy trials[3].

Segment Dominance

The oncology segment is forecasted to dominate the clinical trials market, with cancer immunotherapy trials playing a crucial role in introducing new treatments. However, bowel preparation solutions like NuLytely remain essential for diagnostic procedures such as colonoscopies, which are critical for early detection and treatment of gastrointestinal diseases[3].

Market Projections

Growth Drivers

The growth of the clinical trials market, and by extension the demand for NuLytely, is driven by several factors. These include the advancement of healthcare interventions, the need for evaluating new treatments and preventive measures, and the increasing participation in clinical trials to access potentially more effective treatments. The ongoing development of new medical interventions and the expanding opportunities in cancer immunotherapy also contribute to market growth[3].

Challenges and Trends

Despite the growth, the market faces challenges such as pricing and access to drugs and medical devices, competition from generic drugs and biosimilars, and the patent cliff. These factors could influence the strategies of pharmaceutical companies, including potential mergers and acquisitions to maintain market share[5].

Future Outlook

In 2025, the life sciences industry, including the market for bowel preparation solutions, is expected to undergo significant transformation driven by digital advancements and scientific innovations. Companies are likely to focus on R&D to enhance their market positions, and there may be increased interest in mergers and acquisitions due to patent expirations and the need to capture new market shares[5].

Key Considerations for NuLytely

Patient Safety

When prescribing NuLytely, it is crucial to consider patient safety, particularly regarding fluid and electrolyte abnormalities. Patients with a history of seizures, cardiac arrhythmias, or renal impairment require special caution. Correcting fluid and electrolyte imbalances before treatment and monitoring patients closely during and after administration is essential[2][4].

Administration Guidelines

Patients should be instructed to drink the solution rapidly, at a rate of 240 mL every 10 minutes, until the desired bowel preparation is achieved. Pediatric patients have specific dosing guidelines, and the solution can be administered via nasogastric tube if necessary[2][4].

Key Takeaways

  • Clinical Trials: NuLytely has been evaluated in clinical trials to ensure its safety and efficacy for bowel preparation.
  • Market Size: The global clinical trials market is growing, with North America and the Asia-Pacific region being key players.
  • Segment Dominance: Oncology trials dominate, but bowel preparation solutions remain vital.
  • Growth Drivers: Advancements in healthcare interventions and increasing participation in clinical trials drive market growth.
  • Challenges: Pricing, competition from generics, and patent expirations are significant challenges.
  • Future Outlook: The market is expected to transform with digital and scientific innovations, with a focus on R&D and potential M&A activities.

FAQs

What is NuLytely used for?

NuLytely is used as a bowel preparation solution before colonoscopy procedures to cleanse the bowel.

What are the common adverse reactions to NuLytely?

Common adverse reactions include nausea, abdominal fullness, bloating, abdominal cramps, vomiting, and anal irritation.

Can NuLytely be used in pediatric patients?

Yes, NuLytely can be used in pediatric patients aged 6 months and older, but it requires careful monitoring for potential hypoglycemia and electrolyte imbalances.

What are the special considerations for prescribing NuLytely?

Special caution is needed for patients with a history of seizures, cardiac arrhythmias, or renal impairment, and fluid and electrolyte abnormalities should be corrected before treatment.

How is NuLytely administered?

Patients should drink the solution rapidly at a rate of 240 mL every 10 minutes until the desired bowel preparation is achieved.

Sources

  1. HalfLytely Bowel Prep System for Colonoscopy - Mental Health Network of Care
  2. NuLytely (Polyethylene Glycol 3350, Sodium Chloride ...) - RxList
  3. Clinical Trials Market Size US$ 90.59 Billion by 2033 and CAGR ... - BioSpace
  4. NuLYTELY (polyethylene glycol 3350, sodium ...) - FDA
  5. 2025 life sciences outlook - Deloitte Insights

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