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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002495-13 | EudraCT Number |
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To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prucalopride | Experimental |
| |
| PEG 3350 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prucalopride | Drug | One 2 mg tablet orally administered on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of High-Amplitude Propagating Contractions (HAPC) | Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors). | over 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Curve (AUC) of All HAPCs | The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold. | over 12 hours post-dose |
| The Mean Amplitude of HAPC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | United States | ||
| UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27270968 | Derived | Miner PB Jr, Camilleri M, Burton D, Achenbach H, Wan H, Dragone J, Mellgard B. Prucalopride induces high-amplitude propagating contractions in the colon of patients with chronic constipation: a randomized study. Neurogastroenterol Motil. 2016 Sep;28(9):1341-8. doi: 10.1111/nmo.12832. Epub 2016 Jun 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRU-PEG | A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period. |
| FG001 | PEG-PRU | Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| ||||||||||||||||||
| Period 2 |
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The Safety Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | PRU-PEG | A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period. |
| BG001 | PEG-PRU |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Number of High-Amplitude Propagating Contractions (HAPC) | Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors). | The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period. | Posted | Least Squares Mean | Standard Error | Number of HAPC with amplitude ≥100mmHg | over 12 hours post-dose |
|
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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 | A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders |
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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 |
| C000595212 | polyethylene glycol 3350 |
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| PEG 3350 | Drug | 13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch). |
|
|
The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs. |
| over 12 hours post-dose |
| Time to First HAPC | The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm. | over 12 hours post-dose |
| Propagation Velocity of HAPC | Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs. | over 12 hours post-dose |
| Duration of HAPC | The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs. | over 12 hours post-dose |
| Motility Index | Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1. | over 12 hours post-dose |
| Leuven |
| 3000 |
| Belgium |
| Barts Health NHS Trust | Whitechapel | London | E1 1BB | United Kingdom |
| NOT COMPLETED |
|
Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
| BG002 | Total | Total of all reporting groups |
| Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
| OG001 | PEG 3350 | 13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch). |
|
|
|
| Secondary | Area Under the Concentration Curve (AUC) of All HAPCs | The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold. | The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period. | Posted | Least Squares Mean | Standard Error | mmHg.sec | over 12 hours post-dose |
|
|
|
|
| Secondary | The Mean Amplitude of HAPC | The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs. | The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period. | Posted | Least Squares Mean | Standard Error | mmHg | over 12 hours post-dose |
|
|
|
|
| Secondary | Time to First HAPC | The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm. | The Pharmacodynamic Analysis Set included all subjects in the Safety Analysis Set who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period. | Posted | Median | 95% Confidence Interval | hours | over 12 hours post-dose |
|
|
|
|
| Secondary | Propagation Velocity of HAPC | Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs. | The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period. | Posted | Least Squares Mean | Standard Error | cm/sec | over 12 hours post-dose |
|
|
|
|
| Secondary | Duration of HAPC | The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs. | The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period. | Posted | Least Squares Mean | Standard Error | sec | over 12 hours post-dose |
|
|
|
|
| Secondary | Motility Index | Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1. | The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period. | Posted | Least Squares Mean | Standard Error | mmHg | over 12 hours post-dose |
|
|
|
| 0 |
| 13 |
| 3 |
| 13 |
| EG001 | Polyethylene Glycol | 13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch). | 0 | 12 | 0 | 12 |
| DIARRHOEA | Gastrointestinal disorders |
|
| NAUSEA | Gastrointestinal disorders |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders |
|
| HEADACHE | Nervous system disorders |
|
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.
| 5-12 hours post-dose |
|