Clinical trial NCT04852120: Compound Sodium Picosulfate Granules for Bowel Preparation in Chinese Population
Official title: A Post-marketing Drug Intensive Monitoring Study of Compound Sodium Picosulfate Granules for Bowel Preparation in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Cleansing
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: DeltaMed
First posted: 2021-04-21
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been prescribed Ferring Compound Sodium Picosulfate Granules at the participating sites will be enrolled.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Known Adverse Drug Reactions (ADRs)
timeFrame: Up to 37(+2) hours after drug administration
measure: Occurrence of Unexpected Adverse Events (AEs)/ADRs
timeFrame: Up to 37(+2) hours after drug administration
measure: Incidence and Risk Factors of Serious Adverse Events (SAEs)/Serious Adverse Drug Reactions (SADRs)
timeFrame: Up to 37(+2) hours after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ferring Investigational Site
city: Dalian
country: China
facility: Ferring Investigational Site
city: Fuzhou
country: China
facility: Ferring Investigational Site
city: Jingdezhen
country: China
facility: Ferring Investigational Site
city: Nanjing
country: China
facility: Ferring Investigational Site
city: Ningbo
country: China
facility: Ferring Investigational Site
city: Qiqihar
country: China
facility: Ferring Investigational Site
city: Xian
country: China
facility: Ferring Investigational Site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: