Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| DeltaMed | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compound Sodium Picosulfate Granules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | 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. |
| 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:
| 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:
|
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Patients who are enrolled in other on-going studies, which prohibit any participation in this non-interventional study.
Not provided
Not provided
Not provided
Not provided
Patients who have been prescribed Ferring Compound Sodium Picosulfate Granules at the participating sites will be enrolled.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferring Investigational Site | Beijing | China | ||||
| Ferring Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
In total, 3000 participants were screened and enrolled.
The trial was performed in 14 investigational sites in China between April 2021 and December 2022
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Posted | Count of Participants | Participants | Up to 37(+2) hours after drug administration |
|
Adverse Events were recorded from signing the informed consent form (ICF) to about 37(+2) hours after first medication.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | +1 833-548-1402 | DK0-Disclosure@ferring.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2021 | Jul 19, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| Up to 37(+2) hours after drug administration |
| 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 | Xi'an | China |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to 37(+2) hours after drug administration |
|
|
|
| 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:
| Posted | Count of Participants | Participants | Up to 37(+2) hours after drug administration |
|
|
|
| 0 |
| 3,000 |
| 1 |
| 3,000 |
| 0 |
| 3,000 |
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Measurements |
|---|---|
|
| Asthenia |
|
| Chest Discomfort |
|
| Dizziness |
|
| Palpitations |
|
| Syncope |
|