Colonoscopy
Conditions
Brief summary
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.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures * Chinese citizen * Males or females aged between 18 and 70 years inclusive * Patients scheduled for colonoscopy * Patients who are able to observe instructions given during the study, and are able to complete the entire study procedure
Exclusion criteria
* Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control * Taking concomitant lithium * Allergy to any ingredient in the study medication * History of gastrointestinal diseases (active ulcers, gastric outlet obstruction, gastric retention, intestinal obstruction) * Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at screening * Active (acute/severe/uncontrolled) Inflammatory Bowel Disease (IBD) * Acute abdominal symptoms (acute intestinal obstruction, intestinal perforation, diverticulitis or appendicitis) * Ascites * History of surgery in upper gastrointestinal tract (gastrectomy, gastric banding, gastric bypass surgery) * History of colorectal surgery (excluding appendectomy, hemorrhoidectomy and endoscopic surgery) * Uncontrolled angina and/or myocardial infarction, congestive heart failure, or uncontrolled hypertension within 3 months prior randomisation * Severe liver damage * Kidney function impairment * Diabetics currently on insulin treatment * Having participated in any other clinical trial during the 3 month prior recruitment * Patients who are unable to act in a legal capacity, unable to meet or perform study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation | day 2 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Response to Acceptability and Tolerability Questionnaire | Day 2 | 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)). |
| Ottawa Scale Score by Colon Segment | Day 2 | Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score |
| Percentage of Successful Completion of Colonoscopy | Day 2 | An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve) |
| Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) | Day 2 | 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 |
| Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation | Day 2 | The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation |
Countries
China
Participant flow
Recruitment details
325 subjects were screened and 300 subjects were randomized at 7 sites in China.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 150 |
| 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. | 150 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Could not afford IMP administration | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Not complete Endoscopy | 2 | 2 |
| Overall Study | Patient Withdrew Consent | 2 | 1 |
Baseline characteristics
| Characteristic | PICOPREP | Hengkang Zhengqing (PEG-ELS) | Total |
|---|---|---|---|
| Age Continuous | 46.44 years STANDARD_DEVIATION 12.88 | 47.15 years STANDARD_DEVIATION 12.63 | 46.80 years STANDARD_DEVIATION 12.74 |
| BMI | 22.91 kg/m2 STANDARD_DEVIATION 2.67 | 23.07 kg/m2 STANDARD_DEVIATION 2.83 | 22.99 kg/m2 STANDARD_DEVIATION 2.75 |
| Sex: Female, Male Female | 86 Participants | 73 Participants | 159 Participants |
| Sex: Female, Male Male | 64 Participants | 77 Participants | 141 Participants |
| Weight | 62.35 kilograms STANDARD_DEVIATION 10.2 | 62.95 kilograms STANDARD_DEVIATION 10.86 | 62.65 kilograms STANDARD_DEVIATION 10.52 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 96 / 146 | 128 / 149 |
| serious Total, serious adverse events | 0 / 146 | 0 / 149 |
Outcome results
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)
Time frame: day 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PICOPREP | The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation | 4.73 units on a scale | Standard Deviation 2.48 |
| Hengkang Zhengqing (PEG-ELS) | The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation | 4.91 units on a scale | Standard Deviation 2.42 |
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
Time frame: Day 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PICOPREP | Ottawa Scale Score by Colon Segment | Ascending | 1.56 units on a scale | Standard Deviation 0.91 |
| PICOPREP | Ottawa Scale Score by Colon Segment | Transverse/descending | 1.43 units on a scale | Standard Deviation 0.87 |
| PICOPREP | Ottawa Scale Score by Colon Segment | Rectosigmoid | 1.25 units on a scale | Standard Deviation 0.9 |
| PICOPREP | Ottawa Scale Score by Colon Segment | Overall fluid content (score) | 0.49 units on a scale | Standard Deviation 0.61 |
| Hengkang Zhengqing (PEG-ELS) | Ottawa Scale Score by Colon Segment | Overall fluid content (score) | 0.62 units on a scale | Standard Deviation 0.64 |
| Hengkang Zhengqing (PEG-ELS) | Ottawa Scale Score by Colon Segment | Ascending | 1.73 units on a scale | Standard Deviation 0.97 |
| Hengkang Zhengqing (PEG-ELS) | Ottawa Scale Score by Colon Segment | Rectosigmoid | 1.23 units on a scale | Standard Deviation 0.92 |
| Hengkang Zhengqing (PEG-ELS) | Ottawa Scale Score by Colon Segment | Transverse/descending | 1.33 units on a scale | Standard Deviation 0.88 |
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)).
Time frame: Day 2
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PICOPREP | Patient Response to Acceptability and Tolerability Questionnaire | Abdominal Bloating | 1.31 units on a scale | Standard Deviation 0.48 |
| PICOPREP | Patient Response to Acceptability and Tolerability Questionnaire | Spasms | 1.13 units on a scale | Standard Deviation 0.41 |
| PICOPREP | Patient Response to Acceptability and Tolerability Questionnaire | Nausea | 1.22 units on a scale | Standard Deviation 0.45 |
| PICOPREP | Patient Response to Acceptability and Tolerability Questionnaire | Vomiting | 1.03 units on a scale | Standard Deviation 0.22 |
| PICOPREP | Patient Response to Acceptability and Tolerability Questionnaire | General Malaise | 1.31 units on a scale | Standard Deviation 0.48 |
| PICOPREP | Patient Response to Acceptability and Tolerability Questionnaire | Ease of Taking Study Medication | 1.52 units on a scale | Standard Deviation 0.73 |
| PICOPREP | Patient Response to Acceptability and Tolerability Questionnaire | Degree of Acceptability to Study Med | 1.46 units on a scale | Standard Deviation 0.65 |
| PICOPREP | Patient Response to Acceptability and Tolerability Questionnaire | Palatability of Study Medication | 1.64 units on a scale | Standard Deviation 0.76 |
| Hengkang Zhengqing (PEG-ELS) | Patient Response to Acceptability and Tolerability Questionnaire | Palatability of Study Medication | 2.62 units on a scale | Standard Deviation 0.92 |
| Hengkang Zhengqing (PEG-ELS) | Patient Response to Acceptability and Tolerability Questionnaire | Abdominal Bloating | 1.45 units on a scale | Standard Deviation 0.72 |
| Hengkang Zhengqing (PEG-ELS) | Patient Response to Acceptability and Tolerability Questionnaire | General Malaise | 1.60 units on a scale | Standard Deviation 0.68 |
| Hengkang Zhengqing (PEG-ELS) | Patient Response to Acceptability and Tolerability Questionnaire | Spasms | 1.12 units on a scale | Standard Deviation 0.42 |
| Hengkang Zhengqing (PEG-ELS) | Patient Response to Acceptability and Tolerability Questionnaire | Degree of Acceptability to Study Med | 2.15 units on a scale | Standard Deviation 0.88 |
| Hengkang Zhengqing (PEG-ELS) | Patient Response to Acceptability and Tolerability Questionnaire | Nausea | 1.64 units on a scale | Standard Deviation 0.77 |
| Hengkang Zhengqing (PEG-ELS) | Patient Response to Acceptability and Tolerability Questionnaire | Ease of Taking Study Medication | 2.08 units on a scale | Standard Deviation 0.87 |
| Hengkang Zhengqing (PEG-ELS) | Patient Response to Acceptability and Tolerability Questionnaire | Vomiting | 1.25 units on a scale | Standard Deviation 0.55 |
Secondary
Percentage of Successful Completion of Colonoscopy
An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)
Time frame: Day 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PICOPREP | Percentage of Successful Completion of Colonoscopy | No | 0 Percentage of Subjects (%) |
| PICOPREP | Percentage of Successful Completion of Colonoscopy | Yes | 100 Percentage of Subjects (%) |
| Hengkang Zhengqing (PEG-ELS) | Percentage of Successful Completion of Colonoscopy | Yes | 100 Percentage of Subjects (%) |
| Hengkang Zhengqing (PEG-ELS) | Percentage of Successful Completion of Colonoscopy | No | 0 Percentage of Subjects (%) |
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
Time frame: Day 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PICOPREP | Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation | No | 139 participants |
| PICOPREP | Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation | Yes | 5 participants |
| Hengkang Zhengqing (PEG-ELS) | Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation | No | 137 participants |
| Hengkang Zhengqing (PEG-ELS) | Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation | Yes | 9 participants |
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
Time frame: Day 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PICOPREP | Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) | Adequate bowel preparation | 4.54 units on a scale | Standard Deviation 2.27 |
| PICOPREP | Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) | Inadequate bowel preparation | 10.00 units on a scale | Standard Deviation 2.35 |
| Hengkang Zhengqing (PEG-ELS) | Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) | Adequate bowel preparation | 4.63 units on a scale | Standard Deviation 2.2 |
| Hengkang Zhengqing (PEG-ELS) | Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score) | Inadequate bowel preparation | 9.22 units on a scale | Standard Deviation 1.2 |