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| ID | Type | Description | Link |
|---|---|---|---|
| M0001-C303 | Other Identifier | Movetis | |
| 2010-022402-40 | EudraCT Number |
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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prucalopride | Experimental | drug |
|
| Placebo | Placebo Comparator |
| |
| PEG 4000 | Active Comparator | 4-20g administered as an oral solution once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prucalopride | Drug | prucalopride
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period | Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills). | Last 4 weeks of double-blind treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period | Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. | Last 4 weeks of double-blind treatment period |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25239590 | Result | Mugie SM, Korczowski B, Bodi P, Green A, Kerstens R, Ausma J, Ruth M, Levine A, Benninga MA. Prucalopride is no more effective than placebo for children with functional constipation. Gastroenterology. 2014 Dec;147(6):1285-95.e1. doi: 10.1053/j.gastro.2014.09.005. Epub 2014 Sep 16. | |
| 27891230 | Derived | van Schaick E, Benninga MA, Levine A, Magnusson M, Troy S. Development of a population pharmacokinetic model of prucalopride in children with functional constipation. Pharmacol Res Perspect. 2016 Jun 1;4(4):e00236. doi: 10.1002/prp2.236. eCollection 2016 Aug. |
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Subjects who completed the 8 week double blind treatment period and wished to continue were re-randomized after the double-blind treatment period to the 16 week open-label treatment period. Out of 215 subjects randomized in the study, 213 subjects received treatment and 2 subjects withdrew consent before treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prucalopride | Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily. |
| FG001 | Placebo | Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching prucalopride oral tablet. |
| FG002 | PEG 4000 (Polyethylene Glycol) | Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Treatment Period (8 Weeks) |
|
| ||||||||||||||||||||||||
| Open-label Treatment Period (16 Weeks) |
|
Safety Set was used for baseline characteristics. The Safety Set includes all subjects who were randomized and received at least 1 dose of investigational product. One randomized subject in each group did not receive investigational product and therefore were not included in the Safety Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prucalopride | Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period | Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills). | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. | Posted | Number | percentage of subjects | Last 4 weeks of double-blind treatment period |
|
Baseline up to Week 24
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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 | Prucalopride (Double-blind Period) | Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| C406662 | prucalopride |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Matching oral solution or oral tablets given once daily |
|
| PEG 4000 | Drug |
|
| Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period | Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills). | Last 4 weeks of double-blind treatment period |
| Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period | Purposefully avoiding defecation. | Over the 8 week double blind treatment period |
| Painful Bowel Movements Score in the Double-Blind Treatment Period | Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain. | Over the 8 week double blind treatment period |
| Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period | Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea. | Over the 8 week double blind treatment period |
| Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period | Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea. | Over the 8 week double blind treatment period |
| Large Diameter Stools in the Double-Blind Treatment Period | Large diameter stools make defecation more difficult. Small diameter stools are better. | Over the 8 week double blind treatment period |
| Abdominal Pain Score in Double-Blind Treatment Period | Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain. | Over the 8 week double blind treatment period |
| Frequency of Toilet Training in the Double-Blind Treatment Period | Only for subjects after acquisition of toileting skills. | Over the 8 week double blind treatment period |
| Number of Rescue Medications Taken in the Double-Blind Treatment Period | Over the 8 week double blind treatment period |
| Time to First SBM in the Double-Blind Treatment Period | After intake of the trial medication on Day 1. | Day 1 onwards |
| Number of SBM Per Week in the Double-Blind Treatment Period | Over the 8 week double blind treatment period |
| Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period | Baseline and over the 8 week double blind treatment period |
| Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period | 2 weeks |
| Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period | 2 weeks |
| Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period | Over the 8 week double blind treatment period |
| Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period | Over the 16 week open label treatment period |
| Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period | Over the 16 week open label treatment period |
| Adverse Event |
|
| Lost to Follow-up |
|
| Did not fulfill inclusion/exclusion |
|
| Lack of Efficacy |
|
| NOT COMPLETED |
|
|
Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Placebo |
Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet. |
|
|
|
| Secondary | Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period | Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. | Posted | Number | percentage of subjects | Last 4 weeks of double-blind treatment period |
|
|
|
|
| Secondary | Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period | Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills). | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Number | percentage of subjects | Last 4 weeks of double-blind treatment period |
|
|
|
|
| Secondary | Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period | Purposefully avoiding defecation. | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | retentions/week | Over the 8 week double blind treatment period |
|
|
|
| Secondary | Painful Bowel Movements Score in the Double-Blind Treatment Period | Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain. | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Over the 8 week double blind treatment period |
|
|
|
| Secondary | Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period | Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea. | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Over the 8 week double blind treatment period |
|
|
|
| Secondary | Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period | Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea. | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Over the 8 week double blind treatment period |
|
|
|
| Secondary | Large Diameter Stools in the Double-Blind Treatment Period | Large diameter stools make defecation more difficult. Small diameter stools are better. | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | large diameter stools/week | Over the 8 week double blind treatment period |
|
|
|
| Secondary | Abdominal Pain Score in Double-Blind Treatment Period | Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain. | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Over the 8 week double blind treatment period |
|
|
|
| Secondary | Frequency of Toilet Training in the Double-Blind Treatment Period | Only for subjects after acquisition of toileting skills. | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | toilet trainings/week | Over the 8 week double blind treatment period |
|
|
|
| Secondary | Number of Rescue Medications Taken in the Double-Blind Treatment Period | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | rescue medications/week | Over the 8 week double blind treatment period |
|
|
|
| Secondary | Time to First SBM in the Double-Blind Treatment Period | After intake of the trial medication on Day 1. | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. | Posted | Median | 95% Confidence Interval | hours | Day 1 onwards |
|
|
|
|
| Secondary | Number of SBM Per Week in the Double-Blind Treatment Period | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | SBM/week | Over the 8 week double blind treatment period |
|
|
|
| Secondary | Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Mean | Standard Deviation | SBM/week | Baseline and over the 8 week double blind treatment period |
|
|
|
| Secondary | Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Number | percentage of subjects | 2 weeks |
|
|
|
|
| Secondary | Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Number | percentage of subjects | 2 weeks |
|
|
|
|
| Secondary | Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Number | percentage of subjects | Over the 8 week double blind treatment period |
|
|
|
|
| Secondary | Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Number | percentage of subjects | Over the 16 week open label treatment period |
|
|
|
|
| Secondary | Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period | Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome. | Posted | Number | percentage of subjects | Over the 16 week open label treatment period |
|
|
|
|
| 5 |
| 106 |
| 53 |
| 106 |
| EG001 | Placebo (Double-blind Period) | Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet. | 2 | 107 | 50 | 107 |
| EG002 | Prucalopride (Open-label Period) | Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily. | 4 | 98 | 44 | 98 |
| EG003 | PEG 4000 (Open-label Period) | Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily. | 1 | 99 | 44 | 99 |
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Moderate |
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| Severe |
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| Very severe |
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| Moderate |
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| Severe |
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| Very severe |
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| Moderately effective |
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| Quite a bit effective |
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| Extremely effective |
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| Moderately effective |
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| Quite a bit effective |
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| Extremely effective |
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| Quite difficult |
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| Quite easy |
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| Very easy |
|