CLINICAL TRIALS PROFILE FOR CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

All Clinical Trials for Citric Acid; Magnesium Oxide; Sodium Picosulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02124447 ↗	Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy	Withdrawn	Medical College of Wisconsin	N/A	2014-06-01	This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four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.
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.
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.
NCT04161599 ↗	Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.	Not yet recruiting	Hospital Universitari Vall d'Hebron Research Institute	Phase 4	2021-09-14	The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation. The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated. No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.
NCT05148494 ↗	TES RCT Fleet Enema vs Oral Mechanical Bowel Prep	Not yet recruiting	Nova Scotia Health Authority	Phase 4	2022-02-01	There is no consensus about the best bowel preparation prior to transanal endoscopic surgery TES). Cleanliness and visibility in the rectosigmoid and rectum are of utmost importance, possibly even more so than during colonoscopy, to facilitate safe, precise and efficient resection of the rectal lesion and potentially adequate closure of the defect. Both Fleet enemas and oral mechanical bowel preparation are considered standard of care in preparation for TES. This single center two arm single blinded randomized controlled trial will compare the effectiveness of Fleet enemas in comparison to Pico Salax oral mechanical bowel preparation in cleansing the rectum as measured by a modified version of the Ottawa Bowel Prep Scale.
NCT05436054 ↗	A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy	Not yet recruiting	Norgine	Phase 4	2022-09-01	The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to visual examination of the large bowel to exclude cancer disease. 400 patients who are referred for colonoscopy to a single center in North Jutland will be randomised either to Picoprep or Plenvu. These patients will then answer a questionnaire prior to colonoscopy. The questionnaire is about the most common expected side effects and the experience of cleansing og intake of the bowel agents. The effect of the two agents will examined using a special scoring system (Harefield) to determine the quality of bowel cleansing. Colonoscopist who evaluate the cleansing is blinded to which agent the patient has taken.

Clinical Trial Conditions for Citric Acid; Magnesium Oxide; Sodium Picosulfate

Condition Name

Condition Name for Citric Acid; Magnesium Oxide; Sodium Picosulfate
Intervention	Trials
Wounds and Injuries	1
Bowel Preparation	1
Bowel Preparation Solutions	1
Colon Disease	1

Condition MeSH

Condition MeSH for Citric Acid; Magnesium Oxide; Sodium Picosulfate
Intervention	Trials
Colonic Diseases	1
Colorectal Neoplasms	1
Wounds and Injuries	1

Clinical Trial Locations for Citric Acid; Magnesium Oxide; Sodium Picosulfate

Trials by Country

Trials by Country for Citric Acid; Magnesium Oxide; Sodium Picosulfate
Location	Trials
United States	10
Spain	3
Canada	1
Russian Federation	1
United Kingdom	1

Trials by US State

Trials by US State for Citric Acid; Magnesium Oxide; Sodium Picosulfate
Location	Trials
Ohio	1
Utah	1
Pennsylvania	1
North Carolina	1
New York	1

Clinical Trial Progress for Citric Acid; Magnesium Oxide; Sodium Picosulfate

Clinical Trial Phase

Clinical Trial Phase for Citric Acid; Magnesium Oxide; Sodium Picosulfate
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for Citric Acid; Magnesium Oxide; Sodium Picosulfate
Clinical Trial Phase	Trials
Not yet recruiting	3
Withdrawn	1
Completed	1

Clinical Trial Sponsors for Citric Acid; Magnesium Oxide; Sodium Picosulfate

Sponsor Name

Sponsor Name for Citric Acid; Magnesium Oxide; Sodium Picosulfate
Sponsor	Trials
Ferring Pharmaceuticals	2
Aalborg University Hospital	1
Medical College of Wisconsin	1

Sponsor Type

Sponsor Type for Citric Acid; Magnesium Oxide; Sodium Picosulfate
Sponsor	Trials
Other	6
Industry	3

Clinical Trials, Market Analysis, and Projections for Sodium Picosulfate, Magnesium Oxide, and Citric Acid

Introduction

Sodium picosulfate, magnesium oxide, and citric acid, commonly known as the SPMC combination, have emerged as a significant advancement in bowel preparation for colonoscopy. This article will delve into the recent clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Efficacy and Safety in Adults

Clinical trials have consistently demonstrated the efficacy and safety of the SPMC combination. A study presented at Digestive Disease Week in 2018 showed that the ready-to-drink SPMC oral solution met both primary and secondary efficacy endpoints, including overall colon cleansing and cleansing of the ascending colon, compared to a split-dose sodium picosulfate, magnesium oxide, and citric acid powder that requires dilution and mixing[1].

Efficacy and Safety in Children

A Phase 3, randomized, assessor-blinded, multicenter study published in 2020 evaluated the efficacy, safety, and tolerability of SPMC in children aged 9-16 years undergoing elective colonoscopy. The results indicated that SPMC was efficacious and safe, with comparable efficacy to polyethylene glycol (PEG) and higher tolerability[3].

Special Populations: Renal Impairment and Diabetes

A post hoc secondary analysis from a randomized, assessor-blinded study published in 2021 focused on the safety, efficacy, and tolerability of the SPMC oral solution in patients with mild or moderate baseline renal impairment or diabetes. The study found that the SPMC oral solution demonstrated efficacious colon cleansing and tolerable bowel preparation in these subgroups, with safety profiles similar to the overall cohort[5].

Market Analysis

Approval and Availability

The SPMC combination has been approved by regulatory bodies in various regions. In the United States, CLENPIQ, a ready-to-drink SPMC oral solution, was approved by the FDA in November 2017 and is currently available[1]. In Europe, a tailored dosing regimen for PICOPREP (sodium picosulfate, magnesium oxide, citric acid) was approved in 2016, enhancing its market presence[2].

Market Competition

The bowel preparation market is competitive, with several products available, including polyethylene glycol (PEG) solutions. However, the SPMC combination, particularly in its ready-to-drink form, offers a unique advantage due to its low volume and ease of administration, which can improve patient compliance and satisfaction[1][3].

Patient Preferences and Compliance

Studies have shown that patients prefer the SPMC combination due to its lower volume and better taste compared to traditional PEG solutions. This preference can lead to higher compliance rates, which are crucial for effective colonoscopy preparations[3].

Market Projections

Growth Potential

The global bowel preparation market is expected to grow significantly due to increasing demand for colonoscopy procedures, driven by rising incidence of colorectal cancer and other gastrointestinal disorders. The SPMC combination is poised to capture a substantial share of this market due to its efficacy, safety, and patient-friendly formulation[1][2].

Expanding Indications

Future clinical trials may explore the use of the SPMC combination for other indications beyond colonoscopy, such as bowel preparation for other endoscopic procedures or surgical interventions. This could further expand its market potential[2].

Regulatory Environment

Regulatory approvals and updates, such as the tailored dosing regimen approved in Europe, will continue to influence the market. Ongoing pharmacovigilance reviews, like those conducted by the FDA, ensure the safety profile of these products, which is essential for maintaining and growing market share[2][4].

Key Takeaways

• Efficacy and Safety: The SPMC combination has demonstrated strong efficacy and safety profiles in both adults and children, as well as in special populations with renal impairment or diabetes.
• Market Approval: Approved by regulatory bodies in the U.S. and Europe, with a unique ready-to-drink formulation.
• Patient Compliance: Higher patient compliance due to lower volume and better taste compared to traditional PEG solutions.
• Growth Potential: Expected to grow significantly in the global bowel preparation market driven by increasing demand for colonoscopy procedures.
• Expanding Indications: Potential for future use in other endoscopic and surgical procedures.

FAQs

Q: What is the SPMC combination used for?

A: The SPMC combination, consisting of sodium picosulfate, magnesium oxide, and citric acid, is used for cleansing the colon as a preparation for colonoscopy in adults and children.

Q: Is the SPMC combination available in different formulations?

A: Yes, it is available in both ready-to-drink oral solution (CLENPIQ) and powder forms that require reconstitution with water (PICOPREP, Prepopik).

Q: How does the SPMC combination compare to polyethylene glycol (PEG) solutions?

A: The SPMC combination has been shown to have comparable efficacy to PEG solutions but with higher tolerability and better patient compliance due to its lower volume and better taste.

Q: Are there any special considerations for patients with renal impairment or diabetes?

A: Studies have shown that the SPMC combination is safe and efficacious in patients with mild or moderate renal impairment or diabetes, with tolerability and safety profiles similar to the overall cohort.

Q: What are the future market projections for the SPMC combination?

A: The SPMC combination is expected to capture a significant share of the growing global bowel preparation market, driven by increasing demand for colonoscopy procedures and its patient-friendly formulation.

Sources

1. Ferring to Present Clinical Data on Efficacy and Safety of CLENPIQ... - Ferring USA.
2. Ferring Pharmaceuticals announces approval of new tailored dosing regimen... - Ferring Pharmaceuticals.
3. Sodium picosulfate, magnesium oxide, citric acid vs polyethylene glycol... - PubMed.
4. Pediatric Postmarketing Pharmacovigilance Review - October 4, 2022 - FDA.
5. Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid... - PubMed.