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Last Updated: April 10, 2025

CLINICAL TRIALS PROFILE FOR OSMOPREP


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All Clinical Trials for OSMOPREP

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01427296 ↗ Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing Completed Bausch Health Americas, Inc. Phase 4 2011-09-16 The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.
NCT01427296 ↗ Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing Completed Valeant Pharmaceuticals International, Inc. Phase 4 2011-09-16 The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for OSMOPREP

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Colon Cleansing[disabled in preview]
Condition Name for OSMOPREP
Intervention Trials
Colon Cleansing 1
[disabled in preview] 0
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Condition MeSH

0[disabled in preview]
Condition MeSH for OSMOPREP
Intervention Trials
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Clinical Trial Locations for OSMOPREP

Trials by Country

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Trials by Country for OSMOPREP
Location Trials
United States 13
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Trials by US State

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Trials by US State for OSMOPREP
Location Trials
Washington 1
Virginia 1
Texas 1
Ohio 1
North Carolina 1
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Clinical Trial Progress for OSMOPREP

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4[disabled in preview]
Clinical Trial Phase for OSMOPREP
Clinical Trial Phase Trials
Phase 4 1
[disabled in preview] 0
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Completed[disabled in preview]
Clinical Trial Status for OSMOPREP
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for OSMOPREP

Sponsor Name

trials000001111111Bausch Health Americas, Inc.Valeant Pharmaceuticals International, Inc.[disabled in preview]
Sponsor Name for OSMOPREP
Sponsor Trials
Bausch Health Americas, Inc. 1
Valeant Pharmaceuticals International, Inc. 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Industry[disabled in preview]
Sponsor Type for OSMOPREP
Sponsor Trials
Industry 2
[disabled in preview] 0
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Clinical Trials, Market Analysis, and Projections for OsmoPrep

Overview of OsmoPrep

OsmoPrep is a prescription medication used to cleanse the bowel in preparation for colonoscopy or other procedures. It contains sodium phosphate, an osmotic laxative that works by drawing water into the bowel to induce bowel movements.

Clinical Trials Experience

Patient Demographics and Safety

Clinical trials for OsmoPrep involved a significant number of patients. In two randomized, investigator-blinded, active-controlled trials, 931 adult patients undergoing elective colonoscopy were evaluated. The mean age of the study population was 60 years, with a range of 20 to 89 years. Of the 599 patients who received at least 48 grams of OsmoPrep, 134 (22%) were 65 years of age or older, and 27 (5%) were 75 years of age or older[1].

Common Adverse Reactions

The most common adverse reactions reported in greater than 3% of patients included nausea, vomiting, and abdominal pain. However, diarrhea was not considered an adverse event since it is part of the efficacy of OsmoPrep[1].

Market Analysis for Osmotic Drug Delivery Systems

Global Market Size and Growth

While OsmoPrep itself is not explicitly mentioned in the broader market analysis, the context of osmotic drug delivery systems is relevant. The global osmotic pumps market, which includes similar controlled drug delivery mechanisms, was valued at USD 7.80 billion in 2023 and is projected to reach USD 8.37 billion by 2032, growing at a CAGR of 7.9% during the forecast period (2024–2032)[2].

Key Drivers and Advantages

Osmotic pumps, like OsmoPrep, offer several advantages, including accurate dosing, reduced frequency of administration, and improved patient compliance. These systems are particularly beneficial for chronic conditions such as diabetes, cardiovascular diseases, and chronic pain. The increasing prevalence of these diseases and advancements in pump design and drug formulation are driving the market growth[2].

Regional Market Performance

North America is the most significant market shareholder for osmotic pumps, driven by advanced healthcare infrastructure, high healthcare expenditure, and technological advancements. The Asia-Pacific region is also witnessing robust growth due to rapid industrialization, urbanization, and economic development, along with supportive government policies and increasing adoption of innovative medical technologies[2].

Market Projections for Bowel Preparation Medications

Growing Demand for Effective Bowel Preparation

The demand for effective bowel preparation medications like OsmoPrep is increasing due to the growing need for colonoscopy and other gastrointestinal procedures. New formulations and delivery methods, such as the DCL-101 Pill Prep, are being developed to improve taste and tolerability, which can enhance patient compliance and market growth[4].

Technological Advancements and Personalized Medicine

The integration of omics technologies in clinical trials, which includes genomic, proteomic, and metabolomic data, is driving the market towards more personalized and effective treatments. This trend is expected to enhance the adoption of targeted therapies, including those using osmotic delivery systems, in the coming years[3].

Challenges and Limitations

Regulatory and Cost Barriers

Despite the growth potential, the market for osmotic drug delivery systems, including OsmoPrep, faces challenges such as high costs and stringent regulatory procedures. These barriers can slow down market growth and limit the widespread adoption of these technologies[2].

Need for Skilled Professionals

The lack of skilled professionals in handling advanced osmotic delivery systems can also hinder market growth. This is particularly relevant in regions where healthcare infrastructure and training programs may not be as advanced[5].

Key Takeaways

  • Clinical Trials: OsmoPrep has been evaluated in clinical trials involving a diverse patient population, with a focus on safety and efficacy.
  • Market Growth: The broader market for osmotic drug delivery systems is growing, driven by the need for controlled and precise drug delivery in chronic conditions.
  • Regional Performance: North America and the Asia-Pacific region are key markets, driven by advanced healthcare infrastructure and increasing adoption of innovative technologies.
  • Technological Advancements: Integration of omics technologies and advancements in drug formulation are expected to drive market growth.
  • Challenges: High costs, regulatory barriers, and the need for skilled professionals are significant challenges.

FAQs

What is the primary use of OsmoPrep?

OsmoPrep is used to cleanse the bowel in preparation for colonoscopy or other gastrointestinal procedures.

What are the common adverse reactions associated with OsmoPrep?

Common adverse reactions include nausea, vomiting, and abdominal pain. However, diarrhea is not considered an adverse event as it is part of the medication's efficacy.

How does the market for osmotic drug delivery systems impact OsmoPrep?

The growing demand for controlled and precise drug delivery systems, particularly for chronic conditions, positively impacts the market for medications like OsmoPrep.

What are the key drivers of the osmotic pumps market?

Key drivers include the increasing prevalence of chronic diseases, advancements in pump design and drug formulation, and the growing preference for personalized medicine.

What are the main challenges facing the market for osmotic drug delivery systems?

High costs, stringent regulatory procedures, and the lack of skilled professionals are significant challenges.

Sources

  1. RxList: OsmoPrep - RxList
  2. StraitsResearch: Osmotic Pumps Market Size, Top Share, Demand, Forecast to 2032
  3. BioSpace: Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034
  4. LWW: A Phase 2 Randomized Trial of DCL-101, a Novel Pill-Based...
  5. Mordor Intelligence: Osmometers Market Report | Industry Analysis, Size & Forecast...

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