Need for Bowel Preparation
Conditions
Brief summary
To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy
Interventions
DRUGPrepopik® ½ Sachet x 2 (9-12 years)
DRUGPrepopik® 1 Sachet x 2 (9-12 years)
DRUGOral polyethylene glycol (PEG) based preparation (9-12 years)
DRUGPrepopik® 1 Sachet x 2 (13-16 years)
DRUGOral polyethylene glycol (PEG) based preparation (13-16 years)
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 9 years to 16 years, inclusive, being scheduled to undergo elective colonoscopy * Subjects must have had 3 or more spontaneous bowel movements per week for 1 month prior to the colonoscopy * Female subjects of childbearing potential must undergo a pregnancy test at screening and again at randomization
Exclusion criteria
* Acute surgical abdominal conditions (e.g., acute obstruction or perforation) * Hospitalized for inflammatory bowel disease * Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic surgical procedures * Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo obstruction, hypomotility syndrome, colon resection) * Ascites * Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus) * Upper gastrointestinal surgery (gastric resection, gastric banding, gastric bypass) * Significant cardiovascular disease as determined by the investigator * If subject has a history of renal insufficiency, serum creatinine and potassium must be within normal limits * Any clinically significant laboratory value at screening, including pre- existing electrolyte abnormality, based on clinical history * Hypersensitivity to active ingredients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Defined by Excellent or Good in the Aronchick Scale | On the day of colonoscopy | Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is excellent or good on this 4-point scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Up to 33 days after colonoscopy | An adverse event (AE) is defined as any untoward medical occurrence in a participant taking part in a clinical trial. Proportion of participants with AE are presented. |
| Number of Participants With Abnormal Findings in Laboratory Tests | From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy | Proportion of participants with abnormal findings in laboratory tests are presented. |
| Number of Participants With Abnormal Findings in Physical Examination | From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy | Complete physical examination was conducted at screening and directed physical examinations at other time-points. Directed physical examinations are presented. |
| Number of Participants Who Took the Assigned Dose for Colon Cleansing | Approx. 1 day (From the day before colonoscopy to the day of colonoscopy) | The proportion of participants who took the assigned dose of Prepopik® was assessed. |
| Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | 1 day of colonoscopy | Subject's Tolerability and Satisfaction Questionnaire consists of three questions. Question (Q)1 was How easy was it to drink the bowel cleanout medicine? and Q2 was How did the bowel cleanout medicine taste?. Q3 had five subparts namely: 1. How often did your tummy hurt since you started the medicine? and 2. How often did you feel fullness in your tummy, since you started the cleanout? and 3. How often did you wake up last night and 4. How often did you feel sick to your stomach (nausea) since you started the cleanout?' and 5. How much were you bothered by going to the washroom since you started the cleanout? Satisfactory was defined as a response of 1 (Very Easy) or 2 (Easy) on Q1 and a response of 1 (Very Well) or 2 (Well) on Q2. Tolerable was defined as a response of 1 (Never) or 2 (Rarely) to the five subparts specified in Q3. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at 9 investigative sites in the United States (US).
Pre-assignment details
Eighty participants were screened out of which 78 participants were randomized in this trial. Two were screening failures (participant not fulfilling inclusion/exclusion criteria \[n=1\], other \[n=1\]).
Participants by arm
| Arm | Count |
|---|---|
| Prepopik® ½ Sachet x 2 (9-12 Years) Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old). | 16 |
| Prepopik® 1 Sachet x 2 (9-12 Years) Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old). | 16 |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old). | 16 |
| Prepopik® 1 Sachet x 2 (13-16 Years) Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in Split Dose method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
Day Before method was the alternative method if Split Dose was not appropriate. In Day Before method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old). | 16 |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old). | 14 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Prepopik® ½ Sachet x 2 (9-12 Years) | Prepopik® 1 Sachet x 2 (9-12 Years) | Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Prepopik® 1 Sachet x 2 (13-16 Years) | Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 10.8 years STANDARD_DEVIATION 1 | 10.5 years STANDARD_DEVIATION 1.21 | 10.4 years STANDARD_DEVIATION 1.2 | 15.0 years STANDARD_DEVIATION 1.03 | 14.9 years STANDARD_DEVIATION 0.92 | 12.2 years STANDARD_DEVIATION 2.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 14 Participants | 15 Participants | 15 Participants | 14 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 5 Participants | 1 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 16 Participants | 11 Participants | 15 Participants | 14 Participants | 71 Participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 8 Participants | 11 Participants | 11 Participants | 53 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 8 Participants | 5 Participants | 3 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 17 | 0 / 15 | 0 / 16 | 0 / 12 |
| other Total, other adverse events | 8 / 15 | 5 / 17 | 6 / 15 | 10 / 16 | 11 / 12 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 | 0 / 15 | 0 / 16 | 0 / 12 |
Outcome results
Primary
Percentage of Participants Defined by Excellent or Good in the Aronchick Scale
Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is excellent or good on this 4-point scale.
Time frame: On the day of colonoscopy
Population: The primary efficacy analysis was based on the intention-to-treat (ITT) analysis set, which included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prepopik® ½ Sachet x 2 (9-12 Years) | Percentage of Participants Defined by Excellent or Good in the Aronchick Scale | 50 percentage of participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Percentage of Participants Defined by Excellent or Good in the Aronchick Scale | 87.5 percentage of participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Percentage of Participants Defined by Excellent or Good in the Aronchick Scale | 81.3 percentage of participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Percentage of Participants Defined by Excellent or Good in the Aronchick Scale | 81.3 percentage of participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Percentage of Participants Defined by Excellent or Good in the Aronchick Scale | 85.7 percentage of participants |
Comparison: Confidence interval (CI) of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.90% CI: [-58.8, 0.8]
Comparison: CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.90% CI: [-25.3, 36.9]
Comparison: CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.90% CI: [-33.5, 26.3]
Secondary
Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire
Subject's Tolerability and Satisfaction Questionnaire consists of three questions. Question (Q)1 was How easy was it to drink the bowel cleanout medicine? and Q2 was How did the bowel cleanout medicine taste?. Q3 had five subparts namely: 1. How often did your tummy hurt since you started the medicine? and 2. How often did you feel fullness in your tummy, since you started the cleanout? and 3. How often did you wake up last night and 4. How often did you feel sick to your stomach (nausea) since you started the cleanout?' and 5. How much were you bothered by going to the washroom since you started the cleanout? Satisfactory was defined as a response of 1 (Very Easy) or 2 (Easy) on Q1 and a response of 1 (Very Well) or 2 (Well) on Q2. Tolerable was defined as a response of 1 (Never) or 2 (Rarely) to the five subparts specified in Q3.
Time frame: 1 day of colonoscopy
Population: The secondary efficacy analysis was based on the ITT analysis set, which included all participants who were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q1-Satisfactory | 9 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 5-Tolerable | 9 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 4-Tolerable | 7 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 1-Tolerable | 4 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q2-Satisfactory | 4 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 2-Tolerable | 9 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 3-Tolerable | 10 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 3-Tolerable | 12 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 2-Tolerable | 8 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q2-Satisfactory | 1 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q1-Satisfactory | 6 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 4-Tolerable | 9 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 1-Tolerable | 9 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 5-Tolerable | 7 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 2-Tolerable | 8 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q1-Satisfactory | 2 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q2-Satisfactory | 5 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 1-Tolerable | 2 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 3-Tolerable | 11 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 4-Tolerable | 7 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 5-Tolerable | 2 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 1-Tolerable | 4 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 3-Tolerable | 7 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q2-Satisfactory | 3 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 5-Tolerable | 5 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 4-Tolerable | 8 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q1-Satisfactory | 8 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 2-Tolerable | 7 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 1-Tolerable | 5 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 5-Tolerable | 2 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 4-Tolerable | 3 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 3-Tolerable | 8 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q2-Satisfactory | 2 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q1-Satisfactory | 4 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire | Q3-Subpart 2-Tolerable | 4 participants |
Secondary
Number of Participants Who Took the Assigned Dose for Colon Cleansing
The proportion of participants who took the assigned dose of Prepopik® was assessed.
Time frame: Approx. 1 day (From the day before colonoscopy to the day of colonoscopy)
Population: The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 2 taken? | 14 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 1 taken? | 15 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 1 taken? | 17 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 2 taken? | 17 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 2 taken? | 3 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 1 taken? | 15 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 1 taken? | 16 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 2 taken? | 15 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 1 taken? | 12 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants Who Took the Assigned Dose for Colon Cleansing | Was dose 2 taken? | 0 participants |
Secondary
Number of Participants With Abnormal Findings in Laboratory Tests
Proportion of participants with abnormal findings in laboratory tests are presented.
Time frame: From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy
Population: The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Erythrocytes (×10^12/L)≤ lower limit(≤3.5×10^12/L) | 0 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Protein (g/L) ≥upper limit (≥80 g/L) | 2 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Leukocytes (×10^9/L) ≤lower limit (≤4×10^9/L) | 1 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Glucose (mmol/L) ≤lower limit (≤2.8 mmol/L) | 0 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Bilirubin (μmol/L) ≥upper limit (≥34 μmol/L) | 1 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Eosinophils (ratio) ≥upper limit (≥5) | 4 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Basophils (ratio) ≥upper limit (≥1) | 2 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Neutrophils (×10^9/L) ≥upper limit (≥10×10^9/L) | 0 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Monocytes (ratio) ≥upper limit (≥5) | 0 participants |
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Lymphocytes (×10^9/L) ≤lower limit (≤1×10^9/L) | 0 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Eosinophils (ratio) ≥upper limit (≥5) | 1 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Basophils (ratio) ≥upper limit (≥1) | 2 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Erythrocytes (×10^12/L)≤ lower limit(≤3.5×10^12/L) | 1 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Leukocytes (×10^9/L) ≤lower limit (≤4×10^9/L) | 2 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Lymphocytes (×10^9/L) ≤lower limit (≤1×10^9/L) | 0 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Monocytes (ratio) ≥upper limit (≥5) | 0 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Neutrophils (×10^9/L) ≥upper limit (≥10×10^9/L) | 0 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Bilirubin (μmol/L) ≥upper limit (≥34 μmol/L) | 0 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Glucose (mmol/L) ≤lower limit (≤2.8 mmol/L) | 1 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Protein (g/L) ≥upper limit (≥80 g/L) | 1 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Monocytes (ratio) ≥upper limit (≥5) | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Glucose (mmol/L) ≤lower limit (≤2.8 mmol/L) | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Erythrocytes (×10^12/L)≤ lower limit(≤3.5×10^12/L) | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Leukocytes (×10^9/L) ≤lower limit (≤4×10^9/L) | 1 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Eosinophils (ratio) ≥upper limit (≥5) | 3 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Lymphocytes (×10^9/L) ≤lower limit (≤1×10^9/L) | 1 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Neutrophils (×10^9/L) ≥upper limit (≥10×10^9/L) | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Basophils (ratio) ≥upper limit (≥1) | 4 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Protein (g/L) ≥upper limit (≥80 g/L) | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Bilirubin (μmol/L) ≥upper limit (≥34 μmol/L) | 0 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Eosinophils (ratio) ≥upper limit (≥5) | 2 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Protein (g/L) ≥upper limit (≥80 g/L) | 2 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Basophils (ratio) ≥upper limit (≥1) | 1 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Erythrocytes (×10^12/L)≤ lower limit(≤3.5×10^12/L) | 0 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Monocytes (ratio) ≥upper limit (≥5) | 1 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Bilirubin (μmol/L) ≥upper limit (≥34 μmol/L) | 0 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Glucose (mmol/L) ≤lower limit (≤2.8 mmol/L) | 1 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Neutrophils (×10^9/L) ≥upper limit (≥10×10^9/L) | 0 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Leukocytes (×10^9/L) ≤lower limit (≤4×10^9/L) | 1 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Lymphocytes (×10^9/L) ≤lower limit (≤1×10^9/L) | 1 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Leukocytes (×10^9/L) ≤lower limit (≤4×10^9/L) | 2 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Glucose (mmol/L) ≤lower limit (≤2.8 mmol/L) | 1 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Lymphocytes (×10^9/L) ≤lower limit (≤1×10^9/L) | 1 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Monocytes (ratio) ≥upper limit (≥5) | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Protein (g/L) ≥upper limit (≥80 g/L) | 2 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Neutrophils (×10^9/L) ≥upper limit (≥10×10^9/L) | 1 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Basophils (ratio) ≥upper limit (≥1) | 1 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Bilirubin (μmol/L) ≥upper limit (≥34 μmol/L) | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Erythrocytes (×10^12/L)≤ lower limit(≤3.5×10^12/L) | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Laboratory Tests | Eosinophils (ratio) ≥upper limit (≥5) | 1 participants |
Secondary
Number of Participants With Abnormal Findings in Physical Examination
Complete physical examination was conducted at screening and directed physical examinations at other time-points. Directed physical examinations are presented.
Time frame: From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy
Population: The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Physical Examination | 0 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Abnormal Findings in Physical Examination | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Abnormal Findings in Physical Examination | 0 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Abnormal Findings in Physical Examination | 0 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Abnormal Findings in Physical Examination | 0 participants |
Secondary
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant taking part in a clinical trial. Proportion of participants with AE are presented.
Time frame: Up to 33 days after colonoscopy
Population: The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prepopik® ½ Sachet x 2 (9-12 Years) | Number of Participants With Adverse Events | 8 participants |
| Prepopik® 1 Sachet x 2 (9-12 Years) | Number of Participants With Adverse Events | 5 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Number of Participants With Adverse Events | 6 participants |
| Prepopik® 1 Sachet x 2 (13-16 Years) | Number of Participants With Adverse Events | 10 participants |
| Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) | Number of Participants With Adverse Events | 11 participants |