Compound Sodium Picosulfate Granules for Bowel Preparation in Chinese Population

A Post-marketing Drug Intensive Monitoring Study of Compound Sodium Picosulfate Granules for Bowel Preparation in Chinese Population

High-quality bowel preparation plays an important role in ensuring a safe and successful X-ray examination, endoscopy or some kinds of bowel surgeries. Inadequate bowel preparation may lead to incomplete examination of the colonic mucosa, may require increased operation time and difficulty, and incur the costs for rescheduling or performing other examinations. Early attention to the influencing factors of bowel cleansing effect and taking positive measures can effectively improve the success rate and diagnosis rate of endoscopic and radiological examinations, and reduce the possibility of postoperative complications and local infections. In 2019, China released the latest "Guidelines for Bowel Preparation Related to Digestive Endoscopy", emphasizing the importance of dietary restrictions and patient notification and education. The "Guideline" also recommends that sodium picosulfate, magnesium oxide, and anhydrous citric acid can be used for bowel preparation before endoscopy and is well tolerated (recommended strength: weak; evidence quality: moderate). The other used colonic cleansing agents also include polyethylene glycol (PEG) electrolyte powder, magnesium salt, sodium phosphate, mannitol and Chinese herbal medicine. Each carries its own properties, indications and safety profiles.

Compound Sodium Picosulfate Granules is a compounded preparation consisting of sodium picosulfate and magnesium citrate. Each sachet contains 10 mg of sodium picosulfate, 3.5 g of magnesium oxide and 12.0 g of citric acid. It is white to slightly yellow crystalline powder, with a slight orange flavour. Sodium picosulfate is transformed by colonic bacteria to form an active metabolite: bis-(p-hydroxyphenyl)-pyridyl-2-methane, Bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react to create magnesium citrate (when dispersed in a solution), which is an osmotic agent that causes water to be retained within the gastrointestinal tract. The stimulant laxative activity of sodium picosulfate together with the osmotic laxative activity of magnesium citrate produces a purgative effect, which can be used to clean the bowel prior to X-ray examination, endoscopy or bowel surgery.

Since its first marketing in the United Kingdom (UK) in December 1980, Compound Sodium Picosulfate Granules has been approved in more than 80 countries and regions, including Germany (2010), France (2010), Spain (2011), Italy (2011), United States (2012) and Japan (2016), under the tradename PICOLAX, PICOPREP or PREPOPIK. In 2018, Compound Sodium Picosulfate Granules was officially approved in China with the indication: for preparation of bowel cleansing prior to X-ray examination, endoscopy or surgery when judged clinically necessary.

Study Overview

• Status: Completed
• Conditions: Bowel Cleansing
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Ferring Investigational Site
  • Dalian, China
    • Ferring Investigational Site
  • Fuzhou, China
    • Ferring Investigational Site
  • Jingdezhen, China
    • Ferring Investigational Site
  • Nanjing, China
    • Ferring Investigational Site
  • Ningbo, China
    • Ferring Investigational Site
  • Qiqihar, China
    • Ferring Investigational Site
  • Xian, China
    • Ferring Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been prescribed Ferring Compound Sodium Picosulfate Granules at the participating sites will be enrolled.

Description

Inclusion Criteria:

• Patients who have been prescribed Ferring Compound Sodium Picosulfate Granules
• Agree to participate in this study and sign the informed consent form (ICF).

Exclusion Criteria:

- Patients who are enrolled in other on-going studies, which prohibit any participation in this non-interventional study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Compound Sodium Picosulfate Granules	Other: No intervention; Compound Sodium Picosulfate Granules administered by the patient prior to X-ray examination, endoscopy or surgery when judged clinically necessary in accordance to usual practice consistent with the local prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Known Adverse Drug Reactions (ADRs)	An adverse drug reaction (ADR) is characterized by the suspicion of a causal relationship between the medicine and the occurrence, i.e. judged as being at least possibly related to treatment by the reporter or a reviewing health professional. An ADR is a response to a medicinal product which is noxious and unintended. This includes adverse reactions which arise from: The use of a medical product within the terms of the marketing authorization;; The use outside the terms of the marketing authorization, including overdose, off-label use, misuse, abuse and medication errors;; Occupational exposure.	Up to 37(+2) hours after drug administration
Occurrence of Unexpected Adverse Events (AEs)/ADRs	Adverse event (AE) is any untoward medical condition or the deterioration of a pre-existing medical condition in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Unexpected adverse reaction refers to a drug reaction whose nature, severity, specificity, or outcome is not consistent with the term or description listed in the current local/regional label. This includes events that may be symptomatically and pathophysiological related to an event listed in the labelling but differ from the event because of greater severity or specificity.	Up to 37(+2) hours after drug administration
Incidence and Risk Factors of Serious Adverse Events (SAEs)/Serious Adverse Drug Reactions (SADRs)	The incidence below is Syncope. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose that: Results in death; Is life-threatening; Is a congenital anomaly/birth defect; Results in persistent or significant disability/incapacity; Results in unplanned inpatient hospitalisation or prolongation of existing hospitalisation; Is an important medical event that may jeopardise the participant or may require intervention to prevent one of the outcomes listed above	Up to 37(+2) hours after drug administration

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Collaborators: DeltaMed
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 000373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No