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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001062-10 | EudraCT Number |
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This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICOPREP day-before dosing schedule | Active Comparator | Both doses administered the day before colonoscopy. |
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| PICOPREP tailored dosing schedule | Experimental | First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICOPREP | Drug | Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale | Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid). | Day 1 (day of colonoscopy) |
| Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale | Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid). | Day 1 (day of colonoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| Ascending Colon Cleansing Responder Status (ITT) | Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules. | Day 1 (day of colonoscopy) |
| Frequency and Intensity of Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures
Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)
Ascites
Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
Severely reduced renal function (Glomerular filtration rate (GFR) <30 (mL/min/1.73 m2))
The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman. Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who do not agree to use one of the following methods of birth control from the day of signing the Informed Consent Form until End of Trial Visit are excluded:
The subject is a breast-feeding or lactating woman
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ed Herriot Hopital (there may be other sites in this country) | Lyon | France | ||||
| Gastroenterologie am Bayerischen Platz (there may be other sites in this country) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28393103 | Derived | Kiesslich R, Schubert S, Mross M, Klugmann T, Klemt-Kropp M, Behnken I, Bonnaud G, Keulen E, Groenen M, Blaker M, Ponchon T, Landry W, Stoltenberg M. Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study. Endosc Int Open. 2017 Apr;5(4):E282-E290. doi: 10.1055/s-0043-102433. |
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Subjects were recruited from 11 sites in Germany, France and the Netherlands from Nov 2014 to Jun 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | PICOPREP Day-before Dosing Schedule | Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution |
| FG001 | PICOPREP Tailored Dosing Schedule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| From baseline (screening) up to day 10 after colonoscopy |
| Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure) | Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic). | From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit) |
| Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis) | Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory. | From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit) |
| Berlin |
| Germany |
| Medisch Centrum Alkmaar (there may be other sites in this country) | Alkmaar | Netherlands |
Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution |
| Intention-to-treat Analysis Set |
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| Per-protocol Analysis Set |
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| Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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The intention-to-treat (ITT) analysis set consisted of all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | PICOPREP Day-before Dosing Schedule | Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution |
| BG001 | PICOPREP Tailored Dosing Schedule | Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale | Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid). | The ITT analysis set consisted of all randomized subjects. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (day of colonoscopy) |
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| Primary | Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale | Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid). | The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (day of colonoscopy) |
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| Secondary | Ascending Colon Cleansing Responder Status (ITT) | Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules. | The ITT analysis set consisted of all randomized subjects. | Posted | Number | percentage of subjects | Day 1 (day of colonoscopy) |
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| Secondary | Frequency and Intensity of Adverse Events | The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received. | Posted | Number | subjects | From baseline (screening) up to day 10 after colonoscopy |
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| Secondary | Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure) | Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic). | The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received. | Posted | Number | subjects | From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit) |
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| Secondary | Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis) | Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory. | The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received. | Posted | Number | subjects | From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit) |
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Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PICOPREP Day-before Dosing Schedule | Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution | 0 | 70 | 4 | 70 | ||
| EG001 | PICOPREP Tailored Dosing Schedule | Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution | 1 | 125 | 14 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA (17.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Anorectal discomfort | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA (17.0) | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
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| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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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 |
| ID | Term |
|---|---|
| C005701 | picosulfate sodium |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points. |
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