A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period

PHASE2CompletedINTERVENTIONAL
Enrollment

417

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

September 30, 2014

Conditions
Faecal Incontinence
Interventions
DRUG

1R, 2S-methoxamine hydrochloride

DRUG

Placebo

Trial Locations (51)

4032

University of Debrecen, Medical and Health Science Center, Debrecen

6720

University of Szeged, Albert Szent-Gyorgyi Clinical Center, Faculty of Medicine, Szeged

14163

Zentrum Fur Darm-Und Beckenchirurgie, Berlin

14193

Martin-Luther-Krankenhaus, Berlin

20132

Chirurgia Gastroenterologica, Milan

20159

Casa Di Cura San Pio X, Milan

29603

USP, Hospital De Marbella, Málaga

33000

Chu Bordeaux - Hopital St Andre, Bordeaux

33170

Seconda Unita Operativa Di Chirurgia Generale, Pordenone

44093

Chu Nantes - Hotel Dieu - Institut Des Maladies De L'Appareil Digestif (IMAD), Nantes

50009

Hospital Clinico Universtiaria Lozana Blesa, Zaragoza

69003

Chu Lyon Groupement Hospitalier Edouard Herriot, Lyon

69115

Universitats-Frauenklink, Heidelberg

70362

Kirurgiska Kliniken Universitetssjukhuset, Örebro

75185

Institute of Surgical Sciences, Uppsala

76031

Chu Rouen - Hopital De Charles Nicolle, Rouen

620 00

Fakultni Nemocnice BRNO, Brno

500 02

Gastroenterologie S R O, Hradec Králové

130 00

Krajska Nemocnice Liberec, Liberec

Egk S.R.O Sanatoriu< Sv, Prague

GEP Clinic S.R.O, Prague

100 34

Fakulni Nemocnice Kralovske, Prague

150 06

Fakultni Nemocnice V Motole, Prague

180 00

Fakultni Nemocnice Na Bulovce, Gynekologicko-Porodnicka Klinika, Prague

Unknown

Dr Laurent Siproudhis, Rennes

Unita Operativa Complessa Patologia Chirurgica A Indirizzo Gastroenterologico, Rome

H-1136

PMC Pannon Medical Center, Budapest

H-1183

Polyclinic for Outpatients, Szakrendelo Intezet, Budapest

H-2600

Javorszky Odon Hopsital, Vac Argenti

H-8200

Csolnoky Ferenc Veszprem, Veszprém

00161

Dipartimento Emergenza Urgenza, Rome

Unita Operativa Complessa Gastroenteroloogia A, Rome

85-079

Nzoz Vitamed, Bydgoszcz

32-420

General And Proctology Surgeon, Gdów

95-015

Centrum Medyczne, Wyzszej Szkoly Informatycznej, Głowno

40-079

Nzoz Mekmed S.C. Przychondnia Lekarska, Katowice

94-238

Nzoz Mikomed, Lodz

14-100

Osrodek Badawczo - Leczniczy Zbigniew Zegota, Ostróda

81-756

Endoskopia, Sopot

21-040

Lubelskie Centrum Diagnostyczne, Świdnik

01-231

Lecznica Prosen SMO Private Medical Health Care Centre, Warsaw

53-333

Ars Medica SC, Wroclaw

08035

Hospital Valle De Hebron, Barcelona

08036

Hospital Clinic De Barcelona, Barcelona

08304

Hospital De Mataro, Mataró

205 02

Pelvic Floor Centre, Malmo

141 86

Enheten For Nedre Abdominell Kirurgi, Stockholm

HA1 3UJ

St Mark's Hospital, London

NW1 2BU

University College Hospital, London

NG7 2UH

Queens Medical Centre, Nottingham

S5 7AU

Nothern General Hopsital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Norgine

INDUSTRY

NCT01656720 - A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period | Biotech Hunter | Biotech Hunter