Bowel Cleansing
Conditions
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.
Interventions
OTHERNo 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.
Sponsors
DeltaMed
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Known Adverse Drug Reactions (ADRs) | Up to 37(+2) hours after drug administration | 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. |
| Occurrence of Unexpected Adverse Events (AEs)/ADRs | Up to 37(+2) hours after drug administration | 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. |
| Incidence and Risk Factors of Serious Adverse Events (SAEs)/Serious Adverse Drug Reactions (SADRs) | Up to 37(+2) hours after drug administration | 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 |
Countries
China
Participant flow
Recruitment details
The trial was performed in 14 investigational sites in China between April 2021 and December 2022
Pre-assignment details
In total, 3000 participants were screened and enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Compound Sodium Picosulfate Granules 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. | 3,000 |
| Total | 3,000 |
Baseline characteristics
| Characteristic | Compound Sodium Picosulfate Granules |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 292 Participants |
| Age, Categorical Between 18 and 65 years | 2700 Participants |
| Age, Continuous | 47.99 years STANDARD_DEVIATION 13.12 |
| Body Mass Index (BMI) | 23.16 kg/m^2 STANDARD_DEVIATION 3.22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3000 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 3000 participants |
| Sex: Female, Male Female | 1546 Participants |
| Sex: Female, Male Male | 1454 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3,000 |
| other Total, other adverse events | 0 / 3,000 |
| serious Total, serious adverse events | 1 / 3,000 |
Outcome results
Primary
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
Time frame: Up to 37(+2) hours after drug administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compound Sodium Picosulfate Granules | Incidence and Risk Factors of Serious Adverse Events (SAEs)/Serious Adverse Drug Reactions (SADRs) | 1 Participants |
Primary
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.
Time frame: Up to 37(+2) hours after drug administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compound Sodium Picosulfate Granules | Incidence of Known Adverse Drug Reactions (ADRs) | Abdominal Pain | 2 Participants |
| Compound Sodium Picosulfate Granules | Incidence of Known Adverse Drug Reactions (ADRs) | Dizziness | 1 Participants |
| Compound Sodium Picosulfate Granules | Incidence of Known Adverse Drug Reactions (ADRs) | Nausea | 2 Participants |
| Compound Sodium Picosulfate Granules | Incidence of Known Adverse Drug Reactions (ADRs) | Vomiting | 6 Participants |
Primary
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.
Time frame: Up to 37(+2) hours after drug administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compound Sodium Picosulfate Granules | Occurrence of Unexpected Adverse Events (AEs)/ADRs | Abdominal Distension | 1 Participants |
| Compound Sodium Picosulfate Granules | Occurrence of Unexpected Adverse Events (AEs)/ADRs | Abnormal Faeces | 1 Participants |
| Compound Sodium Picosulfate Granules | Occurrence of Unexpected Adverse Events (AEs)/ADRs | Amaurosis | 1 Participants |
| Compound Sodium Picosulfate Granules | Occurrence of Unexpected Adverse Events (AEs)/ADRs | Asthenia | 1 Participants |
| Compound Sodium Picosulfate Granules | Occurrence of Unexpected Adverse Events (AEs)/ADRs | Chest Discomfort | 1 Participants |
| Compound Sodium Picosulfate Granules | Occurrence of Unexpected Adverse Events (AEs)/ADRs | Dizziness | 1 Participants |
| Compound Sodium Picosulfate Granules | Occurrence of Unexpected Adverse Events (AEs)/ADRs | Palpitations | 1 Participants |
| Compound Sodium Picosulfate Granules | Occurrence of Unexpected Adverse Events (AEs)/ADRs | Syncope | 1 Participants |