Trial Outcomes & Findings for Compound Sodium Picosulfate Granules for Bowel Preparation in Chinese Population (NCT NCT04852120)

Last Updated: 2024-02-26

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

3000 participants

Primary outcome timeframe

Up to 37(+2) hours after drug administration

Results posted on

2024-02-26

Participant Flow

The trial was performed in 14 investigational sites in China between April 2021 and December 2022

In total, 3000 participants were screened and enrolled.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	3000
Overall Study COMPLETED	3000
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compound Sodium Picosulfate Granules for Bowel Preparation in Chinese Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Compound Sodium Picosulfate Granules n=3000 Participants 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.
Age, Categorical <=18 years	8 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2700 Participants n=99 Participants
Age, Categorical >=65 years	292 Participants n=99 Participants
Age, Continuous	47.99 years STANDARD_DEVIATION 13.12 • n=99 Participants
Sex: Female, Male Female	1546 Participants n=99 Participants
Sex: Female, Male Male	1454 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	3000 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment China	3000 participants n=99 Participants
Body Mass Index (BMI)	23.16 kg/m^2 STANDARD_DEVIATION 3.22 • n=99 Participants

PRIMARY outcome

Timeframe: Up to 37(+2) hours after drug administration

Outcome measures

Outcome measures
Measure	Compound Sodium Picosulfate Granules n=3000 Participants 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.
Incidence of Known Adverse Drug Reactions (ADRs) Abdominal Pain	2 Participants
Incidence of Known Adverse Drug Reactions (ADRs) Dizziness	1 Participants
Incidence of Known Adverse Drug Reactions (ADRs) Nausea	2 Participants
Incidence of Known Adverse Drug Reactions (ADRs) Vomiting	6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Compound Sodium Picosulfate Granules n=3000 Participants 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.
Occurrence of Unexpected Adverse Events (AEs)/ADRs Abdominal Distension	1 Participants
Occurrence of Unexpected Adverse Events (AEs)/ADRs Abnormal Faeces	1 Participants
Occurrence of Unexpected Adverse Events (AEs)/ADRs Amaurosis	1 Participants
Occurrence of Unexpected Adverse Events (AEs)/ADRs Asthenia	1 Participants
Occurrence of Unexpected Adverse Events (AEs)/ADRs Chest Discomfort	1 Participants
Occurrence of Unexpected Adverse Events (AEs)/ADRs Dizziness	1 Participants
Occurrence of Unexpected Adverse Events (AEs)/ADRs Palpitations	1 Participants
Occurrence of Unexpected Adverse Events (AEs)/ADRs Syncope	1 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Compound Sodium Picosulfate Granules n=3000 Participants 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.
Incidence and Risk Factors of Serious Adverse Events (SAEs)/Serious Adverse Drug Reactions (SADRs)	1 Participants

Adverse Events

Compound Sodium Picosulfate Granules

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Compound Sodium Picosulfate Granules n=3000 participants at risk 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.
Nervous system disorders Syncope	0.03% 1/3000 • Number of events 1 • Adverse Events were recorded from signing the informed consent form (ICF) to about 37(+2) hours after first medication.

Other adverse events

Adverse event data not reported

Additional Information

Global Clinical Compliance

Ferring Pharmaceuticals

Phone: +1 833-548-1402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER