Evaluation of Prucalopride in Male Subjects With Chronic Constipation.

PHASE3CompletedINTERVENTIONAL
Enrollment

374

Participants

Timeline

Start Date

September 23, 2010

Primary Completion Date

October 25, 2013

Study Completion Date

October 25, 2013

Conditions
Male Subjects With Chronic Constipation
Interventions
DRUG

Placebo

Placebo matched to Prucalopride tablet orally once daily.

DRUG

Prucalopride

Prucalopride 2 mg tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (\<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.

Trial Locations (73)

1000

4 MHAT, Sofia

1200

Cliniques Universitaires St Luc, Brussels

2018

Gastro-Kliniek cvba, Antwerp

2100

GP / Huisartsenpraktijk De Regenboog, Deurne

2750

CCBR DK Ballerup, Ballerup Municipality

3000

UZ Leuven Gasthuisberg, Leuven

4000

CHU Sart Tilman, Liège

7100

CCBR DK Vejle, Vejle

9000

CCBR DK Aalborg, Aalborg

9230

Private Practice, Wetteren

10629

emovis GmbH, Berlin

11025

Centrul Medical Sana, Bucharest

21079

Service de Gastroenterologie & INSERM CIC-P 803 - CHU de Dijon, Dijon

35000

Hôpital Pontchaillou - Service des Maladies de l'Appareil Digestif, Rennes

36001

KKN a.s., Karlovy Vary

40101

SC Cabinet Medical Dr. Blaj Stefan SRL, Bucharest

41100

ARK Clinical Research, Vendôme

49000

ARK Clinical Research (Jean XXIII), Angers

ARK Clinical Research (Proust), Angers

ARK Clinical Research - Chanzy, Angers

ARK Clinical Research, Avrillé

49124

ARK Clinical Research, Le Plessis-Grammoire

60200

CCBR Czech Republic Brno, Brno

65285

Fachartzpraxis für Innere Medizin, Wiesbaden

69437

Hôpital Edouard Herriot, Lyon

80054

CHU - Hopital Nord, service gastro-enterologie et hepatologie, Amiens

93009

Hopital Avicenne, Centre d'exploitation fonctionnelle et reducation digestive, Bobigny

100410

Centrul Medical Valahia SRL, Ploieşti

300002

Policlinic Algomed SRL, Timișoara

300158

Centrul Medical Tuculanu SRL, Timișoara

400006

Spitalul Clinic Judetean Cluj,Clinica Medicala I, Cluj-Napoca

410163

CMI Dr. Lenghel Augustin, Oradea

530174

Cabinet Medical Dr. Lokos Barna-Csaba, Miercurea-Ciuc

540130

CMI de Gastroenterologie Dobru Daniela, Târgu Mureş

550245

Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu

700506

Gastromedica SRL, Iași

530 02

CCBR Czech Republic Pardubice, Pardubice

100 34

Universtiy Hospital Kralovske Vinhorady, Prague

118 33

MONSE s.r.o., Prague

274 01

Hospital Slany, Slaný

562 01

Orlickoustecka nemocnice, Ústí nad Orlicí

762 75

Krajska Nemocnice T. Bati a.s., Interni oddeleni - klinika IPVZ; Nemocnicni Lekarna, Zlín

Krajska Nemocnice T. Bati a.s., Zlín

06002

Hopital Archet 2- service gastro-enterologie et hepatologie, Nice

Unknown

Cabinet Médical, Thouars

04103

Gastroenterologie und Hepatologie am Johannisplatz, Leipzig

3818 ES

Meander Medisch Centrum, Amersfoort

1081 HV

VU Medisch Centrum, Amsterdam

6191JW

PT&R / PreCare Trial & Recruitment, Beek

6716 RP

Ziekenhuis Gelderse Vallei, Ede

6229 HX

Maastricht Universitair medisch Centrum, Maastricht

3015 CE

Erasmus MC, Rotterdam

3083 AN

Ikazia Ziekenhuis, Rotterdam

85-681

Gabinet Lekarski Janusz Rudziński, Bydgoszcz

20-950

Instytut Medycyny Wsi im. Witolda Chodźki - Zaklad Endoskopowych Badań Kliniczncyh, Lublin

20-954

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Lublin

81-756

Endoskopia Sp. z o.o., Sopot

87-100

Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Chirurgii Ogólnej i Gastroenterologii, Torun

02-653

Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ, Warsaw

03-580

NZOZ Vivamed, Warsaw

010825

"Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila", Bucharest

011426

SC Quantum Medical Center SRL, Bucharest

021978

Endocenter Medicina Integrativa SRL, Bucharest

050524

SC Mediclass Sananova SRL, Bucharest

062272

Centrul Medical Humanitas, Bucharest

BA2 3HT

Oldfield Surgery, Bath

S40 4TE

Avondale Surgery, Chesterfield

CV2 2DX

University Hospital & Warwickshire -, Coventry

DH1 5GA

County Durham & Darlington NHS Foundation Trust, Durham

LE10 2SE

Burbage Surgery, Hinckley

KA12 0AY

Townhead Research, Irvine

M23 9LT

Wythenshawe Hospital, Manchester

CV32 4RA

Sherbourne Medical Centre, Royal Leamington Spa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY