stop_circleTerminated/Withdrawn

Neuropathic pain associated with diabetic peripheral neuropathy

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

Trial purpose

People suffering from diabetes often have high blood sugar levels. Over time this can affect many organs including the nerves in hands and feet and can cause a nerve pain called diabetic neuropathic pain (DNP). There are treatments for DNP but in many patients they do not reach a good pain reduction and have unwanted side effects.
In this trial, the researchers will look at how BAY1817080 works and how safe it is. They will compare it to a placebo or another treatment for DNP called pregabalin. A placebo looks like a treatment but does not have any medicine in it. The researchers will use a placebo to learn if the participants’ results are due to BAY1817080 or if the results could be due to chance. The researchers will also learn more about the right dose of BAY1817080 for these participants.
The trial will include participants who have DNP and either type 1 or type 2 diabetes. It will include about 440 men and women who are at least 18 years old.
This trial will have 2 parts. In Part 1, the participants will take either BAY1817080 or the placebo. These treatments will be taken as a tablet by mouth twice a day for 8 weeks. In Part 2, participants will take BAY 1817080, pregabalin, or a matching placebo of either treatment. BAY1817080 and a placebo will be taken as a tablet by mouth twice a day for 12 weeks. Pregabalin and a placebo will be taken as a capsule by mouth twice a day for 12 weeks.
The participants in Part 1 will visit their trial site 6 times. The participants in Part 2 will visit their trial site 7 times. At these visits, the doctors will ask the participants if they have any health problems, take blood samples, and do a physical exam. They will also ask the participants to complete questionnaires about their pain and other symptoms.

Key Participants Requirements

Sex

All

Age

18 Years

Trial summary

Enrollment Goal
154
Trial Dates
January 2021 - October 2021
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Aalborg UniversitetshospitalAalborg, 9000, Denmark
Completed
Steno Diabetes Center CopenhagenHerlev, 2730, Denmark
Completed
Holbæk SygehusHolbæk, 4300, Denmark
Withdrawn
Aarhus Universitetshospital, SkejbyAarhus N, 8200, Denmark
Withdrawn
ÖbackaklinikenHärnösand, 871 31, Sweden
Withdrawn
Center For Diabetes, Academic Specialist CenterStockholm, 113 65, Sweden
Withdrawn
Universitetssjukhuset LinköpingLinköping, 58185, Sweden
Withdrawn
ClinSmartUppsala, 752 37, Sweden
Terminated
Medect Clinical Trials ABStockholm, 11526, Sweden
Withdrawn
Universitätsklinikum AKH WienWien, 1090, Austria
Withdrawn
Zentrum f. klinische Studien Dr. Hanusch GmbHWien, 1060, Austria
Withdrawn
Klinik HietzingWien, 1130, Austria
Withdrawn
Medizinische Universität InnsbruckInnsbruck, 6020, Austria
Withdrawn
Landeskrankenhaus FeldkirchFeldkirch, 6807, Austria
Terminated
St. JosefskrankenhausHeidelberg, 69115, Germany
Withdrawn
Diabetespraxis Dr. BraunBerlin, 13187, Germany
Terminated
InnoDiab Forschung GmbHEssen, 45136, Germany
Withdrawn
Private Diabetologik Praxis Dr. Täschner / Dr. BonigutLeipzig, 04249, Germany
Terminated
Praxis Hr. Dr. med. Jens TaggeselleMarkkleeberg, 04416, Germany
Terminated
Siteworks GmbHHannover, 30449, Germany
Terminated
DKD Helios Klinik WiesbadenWiesbaden, 65191, Germany
Terminated
Friedrich-Schiller-Uni. JenaJena, 07747, Germany
Completed
Instytut Diabetologii w WarszawieWarszawa, 02-117, Poland
Completed
Diamond Clinic Specjalistyczne Poradnie LekarskieKrakow, 31-559, Poland
Completed
LANDA - Specjalist. Gabinety LekarskieKrakow, 31-156, Poland
Completed
Centrum Badan Klinicznych PI-HouseGdansk, 80-546, Poland
Withdrawn
Twoja Przychodnia-Centrum Medyczne Nowa SolNowa Sol, 67-100, Poland
Completed
Futuremeds sp. z o. o.Wroclaw, 50-088, Poland
Completed
Vita Longa Sp. z o.o.Katowice, 40-748, Poland
Withdrawn
PTC-Primary care Trial CenterGöteborg, 413 45, Sweden
Completed
Kolding SygehusKolding, 6000, Denmark
Withdrawn
Sykehuset Innlandet HF HamarHamar, 2326, Norway
Terminated
Oslo universitetssykehus HF, AkerOslo, 0586, Norway
Terminated
AKTIMED Helse ASHamar, 2317, Norway
Terminated
Oslo Universitetssykehus HF, UllevålOslo, 0450, Norway
Terminated
Diabetologicka a endokrinologicka ambulance, Milan KvapilPraha 4, 149 00, Czechia
Terminated
Clintrial s.r.o.Praha 10, 101 00, Czechia
Terminated
Diabet2, s.r.o.Praha 1, 110 00, Czechia
Terminated
Vestra Clinics s.r.o.Rychnov nad Kneznou, 516 01, Czechia
Terminated
Diabetologicka a endokrinologicka ambulance, Milan Kvapil,Pribram, 261 01, Czechia
Terminated
NEUROHK s.r.oChocen, 565 01, Czechia
Withdrawn
ClinDiab Kft.Budapest, 1089, Hungary
Completed
COROMED SMO KFTPecs, 7623, Hungary
Withdrawn
Belinus Bt.Debrecen, 4025, Hungary
Withdrawn
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6720, Hungary
Withdrawn
Kanizsai Dorottya HospitalNagykanizsa, 8800, Hungary
Terminated
MEDISPEKTRUM s.r.o.Bratislava, 851 04, Slovakia
Withdrawn
Fakultna nemocnica AGEL Skalica, a.s.Skalica, 909 82, Slovakia
Terminated
KONZILIUM s.r.o.Dubnica nad Vahom, 018 41, Slovakia
Terminated
Liptovska nemocnica s poliklinikou MUDr. Ivana StodoluLiptovsky Mikulas, 03123, Slovakia
Terminated
Tatratrial s. r. o.Roznava, 04801, Slovakia
Terminated
NEURES, s.r.o.Krompachy, 053 42, Slovakia
Terminated
Hopital Ambroise PareBoulogne billancourt, 92104, France
Withdrawn
Cochin - ParisPARIS, 75674, France
Terminated
Hopital Carémeau - NîmesNIMES cedex 9, 30029, France
Terminated
Hôpital François Mitterrand - DijonDIJON, 21000, France
Terminated
Hôpital Lariboisière - ParisPARIS, 75475, France
Terminated
emovis GmbHBerlin, 10629, Germany
Terminated
Medamed Studienambulanz GmbHLeipzig, 04315, Germany
Terminated
Tampereen yliopistollinen sairaala, keskussairaalaTampere, 33520, Finland
Terminated
Turun yliopistollinen keskussairaalaTurku, 20520, Finland
Terminated
Health Step Finland OyKuopio, 70100, Finland
Terminated
Diagnos Klaukkalan LääkäriasemaKlaukkala, 01800, Finland
Withdrawn
PRAGLANDIAPraha 5, 150 00, Czechia
Withdrawn
VFN, Fakultni poliklinikaPraha 2, 128 08, Czechia
Withdrawn
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnicePardubice, 530 03, Czechia
Withdrawn
DPCKh Orszagos Hematologiai es Infektologiai IntezetBudapest, 1097, Hungary
Withdrawn
Obudai Egeszsegugyi CentrumBudapest, 1036, Hungary
Withdrawn
Trial Pharma Kft.Gyula, 5700, Hungary
Withdrawn
Trial Pharma Kft.Bekescsaba, 5600, Hungary
Withdrawn
Trial Pharma Kft.Oroshaza, 5900, Hungary
Withdrawn
DIABEDA s.r.o.Bratislava, 83106, Slovakia
Withdrawn
MEDI-DIA s.r.o.Sabinov, 08301, Slovakia
Withdrawn
Fakultna nemocnica NitraNitra, 949 01, Slovakia
Withdrawn
Osaka General Medical CenterOsaka, 558-8558, Japan
Withdrawn
Meitetsu HospitalNagoya, 451-8511, Japan
Withdrawn
Dokkyo Medical University HospitalShimotsuga-gun, 321-0293, Japan
Withdrawn
Japan Red Cross Society Azumino HospitalAzumino, 399-8292, Japan
Withdrawn
Jiyugaoka YAMADA ClinicObihiro, 080-0848, Japan
Withdrawn
Seino Internal Medicine ClinicKoriyama, 963-8851, Japan
Withdrawn
Saiki Central HospitalSaiki, 876-0851, Japan
Withdrawn
Kyosokai AMC NISHI-UMEDA ClinicOsaka, 530-0001, Japan
Withdrawn
Nakakinen ClinicNaka, 311-0113, Japan
Withdrawn
Fukuoka Wajiro HospitalFukuoka, 811-0213, Japan
Withdrawn
Kagoshima University HospitalKagoshima, 890-8520, Japan
Withdrawn
Otsu City HospitalOtsu, 520-0804, Japan
Withdrawn
Nakayama ClinicNagoya, 456-0058, Japan
Withdrawn
Asahikawa City HospitalAsahikawa, 070-8610, Japan
Withdrawn
Nagano Municipal HospitalNagano, 381-8551, Japan
Withdrawn
Yokohama City Minato Red Cross HospitalYokohama, 231-8682, Japan
Withdrawn
Kunisaki Makoto ClinicFukuoka, 819-0168, Japan
Withdrawn
JCHO Shimonoseki Medical CenterShimonoseki, 750-0061, Japan
Withdrawn
Hôpital Gabriel Montpied - Clermont FerrandCLERMONT FERRAND, 63000, France
Withdrawn
Avdelningen för kliniska prövningar AKPÖrebro, 703 62, Sweden

Primary Outcome

  • Change in weekly mean 24-hour average pain intensity score using the 11-point Numeric Rating Scale (NRS) from baseline to the end of intervention
    NRS is an one-item assessment of average neuropathic pain intensity which is presented as an 11-point Likert scale with 0 as “no pain” and 10 as “worst imaginable pain”.
    date_rangeTime Frame:
    Part A: from baseline to end of intervention (in total up to 9 weeks)
  • Change in weekly mean 24-hour average pain intensity score using the 11-point Numeric Rating Scale (NRS) from baseline to the end of intervention
    NRS is an one-item assessment of average neuropathic pain intensity which is presented as an 11-point Likert scale with 0 as “no pain” and 10 as “worst imaginable pain”.
    date_rangeTime Frame:
    Part B: from baseline to end of intervention (in total up to 13 weeks)

Secondary Outcome

  • Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline to the end of intervention
    The Neuropathic Pain Symptom Inventory (NPSI) is a PRO developed to evaluate different symptoms of neuropathic pain.
    date_rangeTime Frame:
    Part A: at visit 2, visit 4 (day 15 +/- 2), visit 5 (day 29 +/-2) and visit 7 EOI (day 57 +/-2). Part B: at visit 2, visit 4 (day 15 +/- 2), visit 5 (day 29 +/-2), visit 7 (day 57 +/-2) and visit 8 EOI (day 85 +/-2).
  • Patient Global Impression of Change (PGI-C) at the end of intervention
    The PGI-C is an one-item, self-reported instrument used to assess patients’ impression of disease severity and change, with a 7-point scale response-option. Scores range from 1 (“very much better”) to 7 (“very much worse”).
    date_rangeTime Frame:
    Part A: at visit 5 (day 29 +/-2) and at end of intervention (day 57 +/- 2). Part B: at visit 5 (day 29 +/-2), at visit 7 (day 57 +/- 2) and at end of intervention (day 85 +/-2)
  • The proportion of participants achieving a ≥30% and a ≥50% reduction in weekly mean 24-hour average pain intensity score (i.e. responder rates using NRS)
    date_rangeTime Frame:
    Part A: from baseline to end of intervention (in total up to 9 weeks). Part B: from baseline to end of intervention (in total up to 13 weeks)
  • Number of participants with treatment emergent adverse events (TEAE)
    date_rangeTime Frame:
    Start of intervention to 14 days after stop of treatment

Trial design

A randomized, placebo-controlled, double-blind, parallel-group, multicenter combined Phase 2a/2b study to assess the efficacy and safety of BAY 1817080 in patients with diabetic neuropathic pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
7