Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICOPREP | Experimental | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy. |
|
| PEG-ELS | Active Comparator | PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICOPREP | Drug |
| ||
| PEG-ELS |
| Measure | Description | Time Frame |
|---|---|---|
| The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation | The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel) | day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Response to Acceptability and Tolerability Questionnaire | On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | China | ||||
| The First Affiliated Hospital, Sun Yat-sen University |
Not provided
325 subjects were screened and 300 subjects were randomized at 7 sites in China.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PICOPREP | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy. |
| FG001 | Hengkang Zhengqing (PEG-ELS) | PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PICOPREP | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy. |
| BG001 | Hengkang Zhengqing (PEG-ELS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation | The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel) | Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale | day 2 |
|
Not provided
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
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 | PICOPREP | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
Not provided
| ID | Term |
|---|---|
| C005701 | picosulfate sodium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 2 |
| Ottawa Scale Score by Colon Segment | Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score | Day 2 |
| Percentage of Successful Completion of Colonoscopy | An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve) | Day 2 |
| Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) | At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality "adequate for clinical diagnostic purposes" (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes | Day 2 |
| Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation | The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation | Day 2 |
| Guangzhou |
| China |
| Drum Tower Hospital | Nanjing | China |
| Changhai Hospital, The Second Military Medical University | Shanghai | China |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China |
| Huazhong Technological University Tongji Medical College Affiliated Union Hospital | Wuhan | China |
| Could not afford IMP administration |
|
| Not complete Endoscopy |
|
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy. |
| OG001 | Hengkang Zhengqing (PEG-ELS) | PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination. |
|
|
| Secondary | Patient Response to Acceptability and Tolerability Questionnaire | On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)). | Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Day 2 |
|
|
|
| Secondary | Ottawa Scale Score by Colon Segment | Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score | All randomized patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale | Day 2 |
|
|
|
| Secondary | Percentage of Successful Completion of Colonoscopy | An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve) | Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set. | Posted | Number | Percentage of Subjects (%) | Day 2 |
|
|
|
| Secondary | Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) | At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality "adequate for clinical diagnostic purposes" (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes | Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set. | Posted | Mean | Standard Deviation | units on a scale | Day 2 |
|
|
|
| Secondary | Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation | The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation | Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set. | Posted | Number | participants | Day 2 |
|
|
|
| 0 |
| 146 |
| 96 |
| 146 |
| EG001 | Hengkang Zhengqing (PEG-ELS) | PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination. | 0 | 149 | 128 | 149 |
| Abdominal Distension | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment |
|
Not provided
| Nausea |
|
| Vomiting |
|
| General Malaise |
|
| Ease of Taking Study Medication |
|
| Degree of Acceptability to Study Med |
|
| Palatability of Study Medication |
|
| Rectosigmoid |
|
| Overall fluid content (score) |
|