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
To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prepopik® ½ Sachet x 2 (9-12 years) | Experimental | Prepopik® ½ Sachet x 2 (9-12 years) |
|
| Prepopik® 1 Sachet x 2 (9-12 years) | Experimental | Prepopik® 1 Sachet x 2 (9-12 years) |
|
| Oral polyethylene glycol (PEG) based preparation (9-12 years) | Active Comparator | Local standard of care |
|
| Prepopik® 1 Sachet x 2 (13-16 years) | Experimental | Prepopik® 1 Sachet x 2 (13-16 years) |
|
| Oral polyethylene glycol (PEG) based preparation (13-16 years) | Active Comparator | Local standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prepopik® ½ Sachet x 2 (9-12 years) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | On the day of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 33 days after colonoscopy |
| Number of Participants With Abnormal Findings in Laboratory Tests |
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 |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | United States | |||
| University California San Diego - Rady's Children's Hospital |
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 were recruited at 9 investigative sites in the United States (US).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2014 | Feb 13, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Prepopik® 1 Sachet x 2 (9-12 years) |
| Drug |
|
|
| Oral polyethylene glycol (PEG) based preparation (9-12 years) | Drug |
|
| Prepopik® 1 Sachet x 2 (13-16 years) | Drug |
|
|
| Oral polyethylene glycol (PEG) based preparation (13-16 years) | Drug |
|
Proportion of participants with abnormal findings in laboratory tests are presented. |
| From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy |
| 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. | From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy |
| Number of Participants Who Took the Assigned Dose for Colon Cleansing | The proportion of participants who took the assigned dose of Prepopik® was assessed. | Approx. 1 day (From the day before colonoscopy to the day of colonoscopy) |
| 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. | 1 day of colonoscopy |
| San Diego |
| California |
| United States |
| IU Medical Center / Riley Hospital | Indianapolis | Indiana | United States |
| John Hopkins | Baltimore | Maryland | United States |
| Stony Brook Children's | Stony Brook | New York | United States |
| Nationwide Children's Hospital | Columbus | Ohio | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | United States |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| FG004 | 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | 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). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | 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. | The primary efficacy analysis was based on the intention-to-treat (ITT) analysis set, which included all participants who were randomized. | Posted | Number | 90% Confidence Interval | percentage of participants | On the day of colonoscopy |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Number | participants | Up to 33 days after colonoscopy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Findings in Laboratory Tests | Proportion of participants with abnormal findings in laboratory tests are presented. | 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). | Posted | Number | participants | From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Number | participants | From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Number | participants | Approx. 1 day (From the day before colonoscopy to the day of colonoscopy) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | The secondary efficacy analysis was based on the ITT analysis set, which included all participants who were randomized. | Posted | Number | participants | 1 day of colonoscopy |
|
AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set.
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).
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 | 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). | 0 | 15 | 0 | 15 | 8 | 15 |
| EG001 | 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). | 0 | 17 | 0 | 17 | 5 | 17 |
| EG002 | 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). | 0 | 15 | 0 | 15 | 6 | 15 |
| EG003 | 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). | 0 | 16 | 0 | 16 | 10 | 16 |
| EG004 | 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). | 0 | 12 | 0 | 12 | 11 | 12 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Conjunctival hemmorrhage | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Eosinophilic colitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Gastroenteritis eosinophilic | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Gastrointestinal mucosa hyperemia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Intestinal ulcer | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Foot and mouth disease | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Esophageal candidiasis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Hematocrit decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Hemoglobin decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Urine bilirubin increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
None reported
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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2017 | Feb 13, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Treatment Difference |
| 6.3 |
| 2-Sided |
| 90 |
| -25.3 |
| 36.9 |
| Other |
| CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method. | Treatment Difference | -4.5 | 2-Sided | 90 | -33.5 | 26.3 | Other |
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).
| OG002 | 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). |
| OG003 | 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). |
| OG004 | 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). |
|
|
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).
| OG002 | 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). |
| OG003 | 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). |
| OG004 | 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). |
|
|
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). |
| OG002 | Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) | Oral PEG preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old). |
| OG003 | 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). |
| OG004 | 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). |
|
|
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).
| OG002 | 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). |
| OG003 | 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). |
| OG004 | 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). |
|
|
| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
| OG004 | 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). |
|
|