A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic Pain

PHASE2TerminatedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

January 22, 2021

Primary Completion Date

September 23, 2021

Study Completion Date

October 18, 2021

Conditions
Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Interventions
DRUG

BAY1817080

Tablet, intake orally.

DRUG

Placebo for BAY1817080

Tablet, intake orally.

DRUG

Placebo for Pregabalin

Capsule, intake orally.

DRUG

Pregabalin

Capsule, intake orally. Starting dose 75 mg BID first week, increase to 150 mg BID in second week.

Trial Locations (42)

2317

AKTIMED Helse AS, Hamar

2730

Steno Diabetes Center Copenhagen, Herlev

4300

Holbæk Sygehus, Holbæk

6000

Kolding Sygehus, Kolding

7623

Coromed Smo Kft, Pécs

9000

Aalborg Universitetshospital, Aalborg

10629

emovis GmbH, Berlin

11526

Medect Clinical Trials AB, Stockholm

20520

Turun yliopistollinen keskussairaala, Turku

21000

Hôpital François Mitterrand - Dijon, Dijon

30029

Hopital Carémeau - Nîmes, Nîmes

30449

Siteworks GmbH, Hanover

33520

Tampereen yliopistollinen sairaala, keskussairaala, Tampere

45136

InnoDiab Forschung GmbH, Essen

65191

DKD Helios Klinik Wiesbaden, Wiesbaden

69115

St. Josefskrankenhaus, Heidelberg

70100

Health Step Finland Oy, Kuopio

75475

Hôpital Lariboisière - Paris, Paris

92104

Hopital Ambroise Pare, Boulogne-Billancourt

565 01

NEUROHK s.r.o, Choceň

101 00

Clintrial s.r.o., Prague

110 00

Diabet2, s.r.o., Prague

149 00

Diabetologicka a endokrinologicka ambulance, Milan Kvapil, Prague

261 01

Diabetologicka a endokrinologicka ambulance, Milan Kvapil,, Příbram

516 01

Vestra Clinics s.r.o., Rychnov nad Kněžnou

01800

Diagnos Klaukkalan Lääkäriasema, Klaukkala

04315

Medamed Studienambulanz GmbH, Leipzig

04416

Praxis Hr. Dr. med. Jens Taggeselle, Markkleeberg

07747

Friedrich-Schiller-Uni. Jena, Jena

0450

Oslo Universitetssykehus HF, Ullevål, Oslo

0586

Oslo universitetssykehus HF, Aker, Oslo

80-546

Centrum Badan Klinicznych PI-House, Gdansk

40-748

Vita Longa Sp. z o.o., Katowice

31-156

LANDA - Specjalist. Gabinety Lekarskie, Krakow

31-559

Diamond Clinic Specjalistyczne Poradnie Lekarskie, Krakow

02-117

Instytut Diabetologii w Warszawie, Warsaw

50-088

Futuremeds sp. z o. o., Wroclaw

851 04

MEDISPEKTRUM s.r.o., Bratislava

018 41

KONZILIUM s.r.o., Dubnica nad Váhom

053 42

NEURES, s.r.o., Krompachy

03123

Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu, Liptovský Mikuláš

04801

Tatratrial s. r. o., Rožňava

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY