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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000670-62 | EudraCT Number | ||
| SPD555-401 | Other Identifier | Shire |
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The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.
In this phase IV trial a total of 340 subjects (170 subjects per treatment group), with chronic constipation, are planned to be randomly assigned to double-blind treatment.
The trial duration for a subject can be 26 to 28 weeks in total, including a 2- to 4-week run-in phase followed by a 24-week double-blind treatment phase. The patient will complete an e-diary.
Adult subjects (≥18 to <65 years of age) will take 2 mg prucalopride or matching placebo throughout the entire 24-week treatment period. Elderly subjects (≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo. In case of insufficient response the daily dose has to be increased to 2 mg (i.e. changed to 2 mg prucalopride or matching placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo 2 mg tablet once daily before breakfast |
|
| prucalopride | Active Comparator | Prucalopride 2 mg once daily before breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Placebo matching tablet 2 mg once daily before breakfast for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week 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. | Over 24 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks | Over 24 week treatment period | |
| Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks | Over 24 week treatment period |
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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 |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | Flemish Brabant | 3000 | Belgium | ||
| Cliniques Universitaires St. Luc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39664231 | Derived | Lembo A, Staller K, Boules M, Feuerstadt P, Spalding W, Gabriel A, Youssef A, Xie Y, Terreri B, Cash BD. Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies. Ther Adv Gastroenterol. 2024 Dec 10;17:17562848241299731. doi: 10.1177/17562848241299731. eCollection 2024. | |
| 34585675 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Tablet once daily before breakfast |
| FG001 | Prucalopride | 1 mg or 2 mg tablet once daily before breakfast |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| prucalopride |
| Drug |
Prucalopride 2 mg daily before breakfast 1 mg for subjects >65 years; in case of insufficient response 2 mg at week 2 or week 4 |
|
| Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks | Baseline and Over 24 week treatment period |
| Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week | Over 24 week treatment period |
| Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period | Over 24 week treatment period |
| Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks | Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea. | Baseline and Over 24 week treatment period |
| Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks | Baseline and Over 24 week treatment period |
| Change From Baseline in Straining Per SCBM at Up to 24 Weeks | Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe) | Baseline and Over 24 week treatment period |
| Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks | Baseline and Over 24 week treatment period |
| Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks | Baseline and Over 24 week treatment period |
| Time to First SCBM After Investigational Product Intake on Day 1 and Day 28 | Day 1 and 28 |
| Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks | Baseline and Over 24 week treatment period |
| Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks | Rescue medications include laxatives and enemas. | Baseline and Over 24 week treatment period |
| Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value | The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful. | Baseline and Over 24 week treatment period |
| Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value | The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful. | Baseline and Over 24 week treatment period |
| Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life. | Baseline and Over 24 week treatment period |
| Brussels |
| 1200 |
| Belgium |
| Huisartspraktijk Jaak Mortelmans | Ham | 3945 | Belgium |
| Centre Hospitalier Universitaire Sart Tilman Liège | Liège | 4000 | Belgium |
| Fakultní Thomayerova nemocnice s poliklinikou | Praha 4 - Krc | Prague | 140 59 | Czechia |
| Derma Plus s.r.o. | České Budějovice | 370 01 | Czechia |
| Oblastní nemocnice Kolín, a.s. | Kolín | 280 20 | Czechia |
| Diagnostika a Lécba Zažívacích Chorob, s.r.o. | Ostrava-Hrabuvka | 700 30 | Czechia |
| MONSE s.r.o | Prague | 118 33 | Czechia |
| Nemocnice Tábor, a.s. | Tábor | 390 03 | Czechia |
| Orlickoústecká Nemocnice a.s | Ústí nad Orlicí | 562 18 | Czechia |
| Békés Megyei Képviselotestület Pándy Kálmán Kórháza | Gyula | Bekes County | 5700 | Hungary |
| Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinika | Szeged | Csongrád megye | 6720 | Hungary |
| Dr. Bugyi István Kórház | Szentes | Csongrád megye | 6600 | Hungary |
| Petz Aladár Megyei Oktató Kórház | Győr | Győr-Moson-Sopron | 9024 | Hungary |
| Karolina Kórház Rendelointézet | Mosonmagyaróvar | Győr-Moson-Sopron | 9200 | Hungary |
| Fejér Megyei Szent György Kórház | Székesfehérvár | Pejer | 8000 | Hungary |
| Fundamed Háziorvosi Szövetkezet | Érd | Pest County | 2030 | Hungary |
| UNO Medical Trials, Kft. | Budapest | 1135 | Hungary |
| Pannónia Magánorvosi Centrum Kft. | Budapest | 1136 | Hungary |
| BAZ Megyei és Egyetemi Oktató Kórház | Miskolc | 3526 | Hungary |
| Clinfan Kft. SMO | Szekszárd | 7100 | Hungary |
| CRU Hungary Kft. | Szikszó | 3800 | Hungary |
| Bíró Praxis Kft. | Úrhida | 8142 | Hungary |
| Jávorszky Ödön Városi Kórház | Vác | 2600 | Hungary |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedale San Martino | Genova | 16132 | Italy |
| Policlinico Universitario | Padova | 35128 | Italy |
| Fondazione IRCCS Policlinico S. Matteo | Pavia | 27100 | Italy |
| Policlinico Universitario Campus Biomedico | Roma | 00128 | Italy |
| Azienda Policlinico Umberto I di Roma | Roma | 00161 | Italy |
| Krakowskie Centrum Medyczne NZOZ | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
| Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ | Warsaw | Masovian Voivodeship | 02-653 | Poland |
| Szpital Wojewódzki w Opolu | Opole | Opole Voivodeship | 45-061 | Poland |
| Endoskopia Sp. z o.o. | Sopot | Pomeranian Voivodeship | 81-756 | Poland |
| Centrum Medyczne sw. Lukasza Sp. z o.o. | Częstochowa | Silesian Voivodeship | 42-202 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej "SONOMED" | Szczecin | West Pomeranian Voivodeship | 70-361 | Poland |
| Spitalul Militar Central Bucuresti | Bucharest | Bucharest | 010825 | Romania |
| Centrul Medical Sana | Bucharest | Bucharest | 011025 | Romania |
| Spitalul Clinic Judetean Cluj,Clinica Medicala I | Cluj-Napoca | Cluj | 400006 | Romania |
| Biomed Plus SRL | Craiova | Dolj | 200347 | Romania |
| SC Cabinet Medical Dr. Blaj Stefan SRL | Bucharest | Sector 5 | 040101 | Romania |
| Centrul Medical Tuculanu SRL | Timișoara | Timiș County | 300158 | Romania |
| Endocenter Medicina Integrativa SRL | Bucharest | 021978 | Romania |
| Gastromedica SRL | Iași | 700506 | Romania |
| Spitalul Clinic Judetean de Urgenta Sibiu | Sibiu | 550245 | Romania |
| CMI de Gastroenterologie Dobru Daniela | Târgu Mureş | 540103 | Romania |
| Policlinic Algomed SRL | Timișoara | 300002 | Romania |
| Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion | Bratislava | 811 07 | Slovakia |
| Gastroenterologická ambulancia | Košice | 040 01 | Slovakia |
| PIGEAS s.r.o. | Martin | 03601 | Slovakia |
| Radvanská lekáren, spol. s r.o., | Nitra | 950 01 | Slovakia |
| Gastro I.s.r.o. | Prešov | 08001 | Slovakia |
| GEA s.r.o Gastroenterologicka ambulancia | Trnava | 91701 | Slovakia |
| Hospital Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Nuestra Señora de Valme | Seville | 41014 | Spain |
| Sahlgrenska Universitetsjukhuset | Gothenburg | Västra Götaland County | 413 45 | Sweden |
| Aleris Specialistvård Sabbatsberg | Stockholm | 113 82 | Sweden |
| Karolinska University Hospital Solna | Stockholm | 171 76 | Sweden |
| Derived |
| Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2022 Jan 1;117(1):184-188. doi: 10.14309/ajg.0000000000001521. |
| 25808103 | Derived | Piessevaux H, Corazziari E, Rey E, Simren M, Wiechowska-Kozlowska A, Kerstens R, Cools M, Barrett K, Levine A. A randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of long-term treatment with prucalopride. Neurogastroenterol Motil. 2015 Jun;27(6):805-15. doi: 10.1111/nmo.12553. Epub 2015 Mar 25. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Population was used for demographics. The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Tablet once daily before breakfast |
| BG001 | Prucalopride | 1 mg or 2 mg tablet once daily before breakfast |
| 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, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | This includes all randomized subjects (n = 364). | 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 | The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week 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. | Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. There were 21 subjects with a risk of potential unblinding due to an error in the randomization system who were excluded from the ITT Population to avoid the risk of bias to the study results. | Posted | Number | percentage of subjects | Over 24 week treatment period |
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| Secondary | Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks | Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results. | Posted | Number | percentage of subjects | Over 24 week treatment period |
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| Secondary | Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | SCBM/week | Over 24 week treatment period |
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| Secondary | Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | SCBM/week | Baseline and Over 24 week treatment period |
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| Secondary | Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week | Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results. | Posted | Number | percentage of subjects | Over 24 week treatment period |
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| Secondary | Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period | Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results. | Posted | Number | percentage of subjects | Over 24 week treatment period |
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| Secondary | Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks | Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea. | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Over 24 week treatment period |
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| Secondary | Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | percentage of SCBM | Baseline and Over 24 week treatment period |
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| Secondary | Change From Baseline in Straining Per SCBM at Up to 24 Weeks | Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe) | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Over 24 week treatment period |
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| Secondary | Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | percentage of SCBM | Baseline and Over 24 week treatment period |
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| Secondary | Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | percentage of SBM | Baseline and Over 24 week treatment period |
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| Secondary | Time to First SCBM After Investigational Product Intake on Day 1 and Day 28 | Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results. | Posted | Median | 95% Confidence Interval | hours | Day 1 and 28 |
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| Secondary | Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | tablets/week | Baseline and Over 24 week treatment period |
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| Secondary | Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks | Rescue medications include laxatives and enemas. | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | days/week | Baseline and Over 24 week treatment period |
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| Secondary | Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value | The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful. | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Over 24 week treatment period |
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| Secondary | Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value | The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful. | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Over 24 week treatment period |
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| Secondary | Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life. | ITT population. Not all subjects in the ITT population had data for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Over 24 week treatment period |
|
|
Not provided
The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
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 | Placebo | Tablet once daily before breakfast | 4 | 180 | 23 | 180 | ||
| EG001 | Prucalopride | 1 mg or 2 mg tablet once daily before breakfast | 4 | 181 | 41 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ischemic | Gastrointestinal disorders |
| |||
| Obstruction gastric | Gastrointestinal disorders |
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| Cholecystitis chronic | Hepatobiliary disorders |
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| Vestibular neuronitis | Infections and infestations |
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| Blood pressure decreased | Investigations |
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| Electrocardiogram QT prolonged | Investigations |
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| Cerebrovascular accident | Nervous system disorders |
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| Ischemic stroke | Nervous system disorders |
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| Abnormal behavior | Psychiatric disorders |
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| Orthostatic hypotension | Vascular disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Headache | Nervous system disorders |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D012817 | Signs and Symptoms, Digestive |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C406662 | prucalopride |
Not provided
Not provided
Not provided
| > = 65 years to <75 years |
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| >=75 years |
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| Male |
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| Poland |
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| Italy |
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