CLINICAL TRIALS PROFILE FOR PREPOPIK

All Clinical Trials for PREPOPIK

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03198221 ↗	Comparison of Clenpiq vs Golytely Bowel Preparation	Terminated	Ferring Pharmaceuticals	Phase 4	2018-07-11	This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the procedure.
NCT03198221 ↗	Comparison of Clenpiq vs Golytely Bowel Preparation	Terminated	The Cleveland Clinic	Phase 4	2018-07-11	This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the procedure.
NCT03017235 ↗	A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy	Completed	Ferring Pharmaceuticals	Phase 3	2017-02-20	The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.
NCT01928862 ↗	Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy	Completed	Ferring Pharmaceuticals	Phase 1/Phase 2	2014-06-03	To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy
NCT02124447 ↗	Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy	Withdrawn	Medical College of Wisconsin	N/A	2014-06-01	This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.
NCT01978509 ↗	The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies	Terminated	Mayo Clinic	N/A	2013-09-01	The purpose of this study is to compare the efficacy of a low-volume bowel preparation versus a high-volume bowel preparation for bowel cleansing on hospitalized patients undergoing colonoscopies.

Clinical Trial Conditions for PREPOPIK

Condition Name

Condition Name for PREPOPIK
Intervention	Trials
Bowel Preparation	1
Bowel Preparation Solutions	1
Colonoscopy	1
Need for Bowel Preparation	1

Condition MeSH

Condition MeSH for PREPOPIK
Intervention	Trials

Clinical Trial Locations for PREPOPIK

Trials by Country

+

−

Trials by Country for PREPOPIK
Location	Trials
United States	20
Canada	1

Trials by US State

+

−

Trials by US State for PREPOPIK
Location	Trials
Pennsylvania	2
Ohio	2
New York	2
California	2
Alabama	2

Clinical Trial Progress for PREPOPIK

Clinical Trial Phase

Clinical Trial Phase for PREPOPIK
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for PREPOPIK
Clinical Trial Phase	Trials
Completed	2
Terminated	2
Withdrawn	1

Clinical Trial Sponsors for PREPOPIK

Sponsor Name

Sponsor Name for PREPOPIK
Sponsor	Trials
Ferring Pharmaceuticals	3
Mayo Clinic	1
Medical College of Wisconsin	1

Sponsor Type

Sponsor Type for PREPOPIK
Sponsor	Trials
Other	3
Industry	3

Clinical Trials, Market Analysis, and Projections for PREPOPIK

Introduction

PREPOPIK, a dual-acting stimulant and osmotic laxative, has been a significant player in the colonoscopy bowel preparation market. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Adult Studies

PREPOPIK has been extensively studied in adult populations through the SEE CLEAR I and II pivotal studies. These studies compared PREPOPIK to a standard preparation of 2 liters of polyethylene glycol (PEG) plus electrolytes and two 5-mg bisacodyl tablets. The results showed that PREPOPIK demonstrated effective colon cleansing, achieving non-inferiority to the comparator in both split-dose and day-before dosing regimens. In fact, PREPOPIK showed statistical superiority in some pre-specified analyses, particularly in the split-dose regimen[1][4].

Pediatric Studies

In pediatric patients aged 9-16 years, PREPOPIK was evaluated in a clinical trial (Trial 000103). The study found that PREPOPIK was as effective as the standard PEG preparation in achieving successful colon cleansing. The success rates were similar between PREPOPIK and PEG in both the 9-12 and 13-16 year age groups. However, the study also highlighted the need for caution regarding potential hypoglycemia and orthostatic changes in pediatric patients[2][4].

Efficacy and Safety

Efficacy

PREPOPIK's efficacy has been well-documented. It is the lowest volume active prep solution available, requiring only 10 ounces of prep solution, which enhances patient compliance. The Aronchick and Ottawa scales were used to assess colon cleansing, with PREPOPIK achieving high success rates in both primary and secondary endpoints[1][4].

Safety

The safety profile of PREPOPIK is generally favorable. Common adverse reactions include nausea, headache, and vomiting, which are similar to or slightly lower than those observed with the comparator. However, pediatric studies noted a higher incidence of orthostatic changes and the potential for hypoglycemia, which are important considerations for pediatric use[1][2].

Market Analysis

Global Market Size and Growth

The global colonoscopy bowel preparation drugs market is projected to grow significantly. By 2027, the market is expected to reach $4.5 billion at a CAGR of 7.2%. This growth is driven by the increasing prevalence of colorectal cancer and the need for effective bowel preparation solutions[5].

Market Segmentation

The market is segmented into various drug types, including isotonic agents (like PEG preparations), hypersosmotic agents (such as sodium sulfate and magnesium citrate), and combination agents. PREPOPIK falls under the category of combination agents, which combine stimulant and osmotic properties[5].

Distribution Channels

The market is also segmented by distribution channels, including hospital pharmacies, retail pharmacies, and others. PREPOPIK is available by prescription in U.S. pharmacies and is likely distributed through these channels[5].

Regional Analysis

North America is expected to register a robust revenue CAGR due to the increasing rate of colorectal cancer. Other regions, such as Europe and the Asia Pacific, also contribute significantly to the market growth. The Asia Pacific region is expected to expand at the fastest CAGR due to the increasing prevalence of infectious and chronic diseases[3][5].

Market Projections

Growth Drivers

The growth of the colonoscopy bowel preparation market is driven by several factors, including the rising prevalence of chronic diseases, increased R&D expenditure by pharmaceutical companies, and the need for effective and patient-friendly bowel preparation solutions. PREPOPIK, with its low volume and dual-action mechanism, is well-positioned to benefit from these trends[3][5].

Competitive Landscape

The market is competitive, with several key players adopting strategies such as collaborations and acquisitions to enhance their market share. PREPOPIK's unique features, such as its low volume and split-dose regimen, make it a competitive option in this landscape[5].

Key Takeaways

• Efficacy: PREPOPIK has demonstrated effective colon cleansing in both adult and pediatric populations.
• Safety: While generally safe, PREPOPIK requires caution regarding potential hypoglycemia and orthostatic changes in pediatric patients.
• Market Growth: The global colonoscopy bowel preparation market is expected to grow significantly, driven by increasing disease prevalence and R&D investments.
• Market Position: PREPOPIK is well-positioned due to its low volume and dual-action mechanism, making it a preferred choice for patients and healthcare providers.

FAQs

What is PREPOPIK used for?

PREPOPIK is used for the cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients aged 9 and above.

How does PREPOPIK compare to other bowel preparation solutions?

PREPOPIK is the lowest volume active prep solution available, requiring only 10 ounces of prep solution, and has demonstrated non-inferiority to standard PEG preparations in clinical trials.

What are the common adverse reactions associated with PREPOPIK?

Common adverse reactions include nausea, headache, and vomiting. In pediatric patients, there is also a risk of orthostatic changes and potential hypoglycemia.

Can PREPOPIK be used in pediatric patients?

Yes, PREPOPIK has been studied and found effective in pediatric patients aged 9-16 years, though with certain precautions regarding hypoglycemia and orthostatic changes.

What is the projected growth of the colonoscopy bowel preparation market?

The global colonoscopy bowel preparation market is expected to reach $4.5 billion by 2027 at a CAGR of 7.2%.

Sources

1. PR Newswire: Study Results Show PREPOPIK™ (Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid) Demonstrates Successful Colon Cleansing...
2. FDA: UNIFIED CLINICAL/STATISTICAL REVIEW - FDA
3. Fortune Business Insights: Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]
4. FDA: 209589Orig1s000 - accessdata.fda.gov
5. GlobeNewswire: Global Colonoscopy Bowel Preparation Drugs Market Report 2023: Sector to Reach $4.5 Billion by 2027 at a 7.2% CAGR.