NCT01939366 - Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves | Biotech Hunter

Enrollment

699

Participants

Timeline

Start Date

September 27, 2013

Primary Completion Date

January 31, 2015

Study Completion Date

January 28, 2015

Conditions

Chronic PainDiabetic NeuropathiesDiabetes Mellitus

Interventions

DRUG

Cebranopadol 100 µg

Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.

DRUG

Cebranopadol 300 µg

Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.

DRUG

Cebranopadol 600 µg

Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.

DRUG

Pregabalin

Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.

DRUG

Matching Placebo

Placebo will be matched to pregabalin and cebranopadol.

Trial Locations (82)

1010

AT002, Vienna

1060

AT003, Vienna

1090

AT001, Vienna

1160

AT006, Vienna

2000

DK002, Copenhagen

3541

AT004, Senftenberg

5000

DK001, Odense

5020

AT005, Salzburg

8000

DK003, Aarhus

8036

AT007, Graz

9100

DK005, Aalborg

10115

DE005, Berlin

10117

DE023, Berlin

10126

IT002, Turin

10128

US021, New York

10787

DE031, Berlin

11229

US008, Brooklyn

11235

US005, Brooklyn

12627

DE004, Berlin

13125

DE025, Berlin

16002

ES001, Cuenca

19055

DE024, Schwerin

20162

IT004, Milan

20253

DE021, Hamburg

24119

DE002, Kiel

28031

ES011, Madrid

28040

ES010, Madrid

28041

ES009, Madrid

30159

DE020, Hanover

32545

DE003, Bad Oeynhausen

32806

US009, Orlando

33012

US011, Hialeah

33135

US012, Miami

39104

DE015, Magdeburg

39112

DE032, Magdeburg

40210

DE017, Düsseldorf

40212

DE012, Düsseldorf

41460

DE011, Neuss

44200

FR002, Nantes

44787

DE013, Bochum

45000

FR004, Orléans

45136

DE010, Essen

45277

DE034, Essen

45355

DE022, Essen

45600

ES003, Toledo

46010

ES006, Valencia

48145

DE014, Münster

55116

DE001, Mainz

56727

DE028, Mayen

59037

FR001, Lille

60123

US006, Elgin

60127

IT005, Ancona

60596

DE006, Frankfurt

63739

DE018, Aschaffenburg

75004

FR006, Paris

76199

DE016, Karlsruhe

81477

DE027, München

82013

FR005, Montauban

83221

US004, Blackfoot

84088

US003, West Jordan

85215

US002, Mesa

87042

FR007, Limoges

91100

FR008, Corbeil-Essonnes

91950

US014, National City

92653

US019, Laguna Hills

92843

US001, Garden Grove

92868

US007, Orange

94550

DE030, Künzing

07764

US016, West Long Branch

01069

DE033, Dresden

02826

DE007, Görlitz

04103

DE008, Leipzig

04109

DE009, Leipzig

00133

IT001, Rome

1091 AC

NL007, Amsterdam

7334 DZ

NL004, Apeldoorn

6191 JW

NL005, Beek

5623 EJ

NL001, Eindhoven

3039 BD

NL002, Rotterdam

5912 BL

NL006, Venlo

3331 LZ

NL008, Zwijndrecht

8025 AB

NL003, Zwolle

All Listed Sponsors

lead

Tris Pharma, Inc.

INDUSTRY