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Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years (SPD555-401)

Primary Purpose

Constipation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
placebo
prucalopride
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Long term, Constipation, Digestive signs and symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).
  2. Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).
  3. Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [bisacodyl/enemas].

Exclusion Criteria:

  1. Subjects in whom constipation is thought to be drug-induced
  2. Subjects using any disallowed medication.
  3. Subjects who previously used prucalopride.
  4. Subjects suffering from secondary causes of chronic constipation.

Sites / Locations

  • Universitaire Ziekenhuizen Leuven
  • Cliniques Universitaires St. Luc
  • Huisartspraktijk Jaak Mortelmans
  • Centre Hospitalier Universitaire Sart Tilman Liège
  • Fakultní Thomayerova nemocnice s poliklinikou
  • Derma Plus s.r.o.
  • Oblastní nemocnice Kolín, a.s.
  • Diagnostika a Lécba Zažívacích Chorob, s.r.o.
  • MONSE s.r.o
  • Nemocnice Tábor, a.s.
  • Orlickoústecká Nemocnice a.s
  • Békés Megyei Képviselotestület Pándy Kálmán Kórháza
  • Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinika
  • Dr. Bugyi István Kórház
  • Petz Aladár Megyei Oktató Kórház
  • Karolina Kórház Rendelointézet
  • Fejér Megyei Szent György Kórház
  • Fundamed Háziorvosi Szövetkezet
  • UNO Medical Trials, Kft.
  • Pannónia Magánorvosi Centrum Kft.
  • BAZ Megyei és Egyetemi Oktató Kórház
  • Clinfan Kft. SMO
  • CRU Hungary Kft.
  • Jávorszky Ödön Városi Kórház
  • Bíró Praxis Kft.
  • Istituto Clinico Humanitas
  • Azienda Ospedale San Martino
  • Policlinico Universitario
  • Fondazione IRCCS Policlinico S. Matteo
  • Policlinico Universitario Campus Biomedico
  • Azienda Policlinico Umberto I di Roma
  • Krakowskie Centrum Medyczne NZOZ
  • Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ
  • Szpital Wojewódzki w Opolu
  • Endoskopia Sp. z o.o.
  • Centrum Medyczne sw. Lukasza Sp. z o.o.
  • Niepubliczny Zaklad Opieki Zdrowotnej "SONOMED"
  • Spitalul Militar Central Bucuresti
  • Centrul Medical Sana
  • Spitalul Clinic Judetean Cluj,Clinica Medicala I
  • Biomed Plus SRL
  • SC Cabinet Medical Dr. Blaj Stefan SRL
  • Centrul Medical Tuculanu SRL
  • Endocenter Medicina Integrativa SRL
  • Gastromedica SRL
  • Spitalul Clinic Judetean de Urgenta Sibiu
  • CMI de Gastroenterologie Dobru Daniela
  • Policlinic Algomed SRL
  • Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion
  • Gastroenterologická ambulancia
  • PIGEAS s.r.o.
  • Radvanská lekáren, spol. s r.o.,
  • Gastro I.s.r.o.
  • GEA s.r.o Gastroenterologicka ambulancia
  • Hospital Parc Tauli
  • Hospital Clínico San Carlos
  • Hospital Universitario Nuestra Señora de Valme
  • Sahlgrenska Universitetsjukhuset
  • Aleris Specialistvård Sabbatsberg
  • Karolinska University Hospital Solna

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

prucalopride

Arm Description

Placebo 2 mg tablet once daily before breakfast

Prucalopride 2 mg once daily before breakfast

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks
Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks
Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-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.
Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks
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)
Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks
Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks
Time to First SCBM After Investigational Product Intake on Day 1 and Day 28
Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks
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.
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.
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.
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.

Full Information

First Posted
August 25, 2011
Last Updated
June 1, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01424228
Brief Title
Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years
Acronym
SPD555-401
Official Title
A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2011 (Actual)
Primary Completion Date
December 19, 2012 (Actual)
Study Completion Date
December 19, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Long term, Constipation, Digestive signs and symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 2 mg tablet once daily before breakfast
Arm Title
prucalopride
Arm Type
Active Comparator
Arm Description
Prucalopride 2 mg once daily before breakfast
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo matching tablet 2 mg once daily before breakfast for 24 weeks
Intervention Type
Drug
Intervention Name(s)
prucalopride
Intervention Description
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
Primary Outcome Measure Information:
Title
The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period
Description
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.
Time Frame
Over 24 week treatment period
Secondary Outcome Measure Information:
Title
Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks
Time Frame
Over 24 week treatment period
Title
Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks
Time Frame
Over 24 week treatment period
Title
Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks
Time Frame
Baseline and Over 24 week treatment period
Title
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week
Time Frame
Over 24 week treatment period
Title
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period
Time Frame
Over 24 week treatment period
Title
Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks
Description
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.
Time Frame
Baseline and Over 24 week treatment period
Title
Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks
Time Frame
Baseline and Over 24 week treatment period
Title
Change From Baseline in Straining Per SCBM at Up to 24 Weeks
Description
Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)
Time Frame
Baseline and Over 24 week treatment period
Title
Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks
Time Frame
Baseline and Over 24 week treatment period
Title
Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks
Time Frame
Baseline and Over 24 week treatment period
Title
Time to First SCBM After Investigational Product Intake on Day 1 and Day 28
Time Frame
Day 1 and 28
Title
Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks
Time Frame
Baseline and Over 24 week treatment period
Title
Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks
Description
Rescue medications include laxatives and enemas.
Time Frame
Baseline and Over 24 week treatment period
Title
Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value
Description
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.
Time Frame
Baseline and Over 24 week treatment period
Title
Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value
Description
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.
Time Frame
Baseline and Over 24 week treatment period
Title
Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value
Description
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.
Time Frame
Baseline and Over 24 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit). Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM). Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [bisacodyl/enemas]. Exclusion Criteria: Subjects in whom constipation is thought to be drug-induced Subjects using any disallowed medication. Subjects who previously used prucalopride. Subjects suffering from secondary causes of chronic constipation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cliniques Universitaires St. Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Huisartspraktijk Jaak Mortelmans
City
Ham
ZIP/Postal Code
3945
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Sart Tilman Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Fakultní Thomayerova nemocnice s poliklinikou
City
Praha 4 - Krc
State/Province
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Derma Plus s.r.o.
City
Ceské Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Oblastní nemocnice Kolín, a.s.
City
Kolin
ZIP/Postal Code
280 20
Country
Czechia
Facility Name
Diagnostika a Lécba Zažívacích Chorob, s.r.o.
City
Ostrava-Hrabuvka
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
MONSE s.r.o
City
Praha 1
ZIP/Postal Code
118 33
Country
Czechia
Facility Name
Nemocnice Tábor, a.s.
City
Tabor
ZIP/Postal Code
390 03
Country
Czechia
Facility Name
Orlickoústecká Nemocnice a.s
City
Ústí nad Orlicí
ZIP/Postal Code
562 18
Country
Czechia
Facility Name
Békés Megyei Képviselotestület Pándy Kálmán Kórháza
City
Gyula
State/Province
Bekes
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinika
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Dr. Bugyi István Kórház
City
Szentes
State/Province
Csongrad
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Gyor
State/Province
Gyor-moson-sopron
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Karolina Kórház Rendelointézet
City
Mosonmagyaróvar
State/Province
Gyor-moson-sopron
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Fejér Megyei Szent György Kórház
City
Székesfehérvár
State/Province
Pejer
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Fundamed Háziorvosi Szövetkezet
City
Érd
State/Province
Pest
ZIP/Postal Code
2030
Country
Hungary
Facility Name
UNO Medical Trials, Kft.
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Pannónia Magánorvosi Centrum Kft.
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
BAZ Megyei és Egyetemi Oktató Kórház
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Clinfan Kft. SMO
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
CRU Hungary Kft.
City
Szikszó
ZIP/Postal Code
3800
Country
Hungary
Facility Name
Jávorszky Ödön Városi Kórház
City
Vác
ZIP/Postal Code
2600
Country
Hungary
Facility Name
Bíró Praxis Kft.
City
Úrhida
ZIP/Postal Code
8142
Country
Hungary
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedale San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Policlinico Universitario
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Fondazione IRCCS Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Policlinico Umberto I di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Krakowskie Centrum Medyczne NZOZ
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-653
Country
Poland
Facility Name
Szpital Wojewódzki w Opolu
City
Opole
State/Province
Opolskie
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Centrum Medyczne sw. Lukasza Sp. z o.o.
City
Czestochowa
State/Province
Slaskie
ZIP/Postal Code
42-202
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej "SONOMED"
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-361
Country
Poland
Facility Name
Spitalul Militar Central Bucuresti
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Centrul Medical Sana
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
Spitalul Clinic Judetean Cluj,Clinica Medicala I
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Biomed Plus SRL
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Facility Name
SC Cabinet Medical Dr. Blaj Stefan SRL
City
Bucharest
State/Province
Sector 5
ZIP/Postal Code
040101
Country
Romania
Facility Name
Centrul Medical Tuculanu SRL
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300158
Country
Romania
Facility Name
Endocenter Medicina Integrativa SRL
City
Bucuresti
ZIP/Postal Code
021978
Country
Romania
Facility Name
Gastromedica SRL
City
Iasi
ZIP/Postal Code
700506
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sibiu
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
CMI de Gastroenterologie Dobru Daniela
City
Targu-Mures
ZIP/Postal Code
540103
Country
Romania
Facility Name
Policlinic Algomed SRL
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion
City
Bratislava
ZIP/Postal Code
811 07
Country
Slovakia
Facility Name
Gastroenterologická ambulancia
City
Košice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
PIGEAS s.r.o.
City
Martin
ZIP/Postal Code
03601
Country
Slovakia
Facility Name
Radvanská lekáren, spol. s r.o.,
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Gastro I.s.r.o.
City
Prešov
ZIP/Postal Code
08001
Country
Slovakia
Facility Name
GEA s.r.o Gastroenterologicka ambulancia
City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
Hospital Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Sahlgrenska Universitetsjukhuset
City
Göteborg
State/Province
Vastra Gotaland
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Aleris Specialistvård Sabbatsberg
City
Stockholm
ZIP/Postal Code
113 82
Country
Sweden
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34585675
Citation
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.
Results Reference
derived
PubMed Identifier
25808103
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years

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