Compound Sodium Picosulfate Granules for Bowel Preparation in Chinese Population

Overview

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) and the United States (2012), 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.

Full Title of Study: “A Post-marketing Drug Intensive Monitoring Study of Compound Sodium Picosulfate Granules for Bowel Preparation in Chinese Population”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2023

Interventions

  • 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.

Arms, Groups and Cohorts

  • Compound Sodium Picosulfate Granules

Clinical Trial Outcome Measures

Primary Measures

  • Incidence and seriousness of known and unexpected adverse events (AEs)/adverse drug reactions (ADRs)
    • Time Frame: Up to 37(+2) hours after drug administration
  • Incidence, seriousness and relatedness of adverse events of special interest (AESIs)
    • Time Frame: Up to 37(+2) hours after drug administration
  • Incidence of serious adverse events (SAEs)/serious adverse drug reactions (SADRs)
    • Time Frame: Up to 37(+2) hours after drug administration
  • Patients with risk factors for known AEs/ADRs, unexpected AEs/ADRs, AESI, and SAEs/SADRs
    • Time Frame: Up to 37(+2) hours after drug administration
    • Number of patients with relevant risk factors for known AEs/ADRs, unexpected AEs/ADRs, AESI, and SAEs/SADRs will be presented.

Secondary Measures

  • Number of patients with compliance to drug administration and liquid intake
    • Time Frame: On Day 1, at time of drug administration
    • Number of patients with compliance to drug administration and liquid intake will be reported. Non-compliance of drug administration was defined per label as having taken a total amount of medication less than 1.5 sachets. Non-compliance of liquid intake defined per label as having taken less than 5 cups of clear liquid (250mL per cup after the first dose or less than 3 cups of clear liquid (250mL per cup) after the second dose.
  • Percentage of patients with compliance to drug administration and liquid intake
    • Time Frame: On Day 1, at time of drug administration
    • Percentage of patients with compliance to drug administration and liquid intake will be reported. Non-compliance of drug administration was defined per label as having taken a total amount of medication less than 1.5 sachets. Non-compliance of liquid intake defined per label as having taken less than 5 cups of clear liquid (250mL per cup after the first dose or less than 3 cups of clear liquid (250mL per cup) after the second dose.
  • Patient drug satisfaction
    • Time Frame: Up to 37(+2) hours after drug administration
    • A self-satisfaction evaluation will be collected on the electronic Patient Reported Outcomes (ePRO) database: ease of consuming, cleansing level of the colon as reaching the clear yellow liquid poop stage, overall experience as well as willingness and acceptance to use for future bowel preparation.
  • Number of patients with risk factors associated with drug use, package and distribution
    • Time Frame: Up to 37(+2) hours after drug administration
    • This information or any risk will be collected in ePRO database (adverse event part). This information will be sent to Pharmacovigilance department for assessment.
  • Percentage of patients with risk factors associated with drug use, package and distribution
    • Time Frame: Up to 37(+2) hours after drug administration
    • This information or any risk will be collected in ePRO database (adverse event part). This information will be sent to Pharmacovigilance department for assessment.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ferring Pharmaceuticals
  • Collaborator
    • DeltaMed
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Global Clinical Compliance, Study Director, Ferring Pharmaceuticals
  • Overall Contact(s)
    • Global Clinical Compliance, +1 833-548-1402 (US/Canada), DK0-Disclosure@ferring.com

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