stop_circleTerminated/Withdrawn
Neuropathic pain associated with diabetic peripheral neuropathy
Bayer Identifier:
20887
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
AllAge
18 YearsTrial summary
Enrollment Goal
154Trial Dates
January 2021 - October 2021Phase
Phase 2Could I Receive a placebo
YesProducts
Eliapixant (BAY1817080)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Aalborg Universitetshospital | Aalborg, 9000, Denmark |
Completed | Steno Diabetes Center Copenhagen | Herlev, 2730, Denmark |
Completed | Holbæk Sygehus | Holbæk, 4300, Denmark |
Withdrawn | Aarhus Universitetshospital, Skejby | Aarhus N, 8200, Denmark |
Withdrawn | Öbackakliniken | Härnösand, 871 31, Sweden |
Withdrawn | Center For Diabetes, Academic Specialist Center | Stockholm, 113 65, Sweden |
Withdrawn | Universitetssjukhuset Linköping | Linköping, 58185, Sweden |
Withdrawn | ClinSmart | Uppsala, 752 37, Sweden |
Terminated | Medect Clinical Trials AB | Stockholm, 11526, Sweden |
Withdrawn | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Withdrawn | Zentrum f. klinische Studien Dr. Hanusch GmbH | Wien, 1060, Austria |
Withdrawn | Klinik Hietzing | Wien, 1130, Austria |
Withdrawn | Medizinische Universität Innsbruck | Innsbruck, 6020, Austria |
Withdrawn | Landeskrankenhaus Feldkirch | Feldkirch, 6807, Austria |
Terminated | St. Josefskrankenhaus | Heidelberg, 69115, Germany |
Withdrawn | Diabetespraxis Dr. Braun | Berlin, 13187, Germany |
Terminated | InnoDiab Forschung GmbH | Essen, 45136, Germany |
Withdrawn | Private Diabetologik Praxis Dr. Täschner / Dr. Bonigut | Leipzig, 04249, Germany |
Terminated | Praxis Hr. Dr. med. Jens Taggeselle | Markkleeberg, 04416, Germany |
Terminated | Siteworks GmbH | Hannover, 30449, Germany |
Terminated | DKD Helios Klinik Wiesbaden | Wiesbaden, 65191, Germany |
Terminated | Friedrich-Schiller-Uni. Jena | Jena, 07747, Germany |
Completed | Instytut Diabetologii w Warszawie | Warszawa, 02-117, Poland |
Completed | Diamond Clinic Specjalistyczne Poradnie Lekarskie | Krakow, 31-559, Poland |
Completed | LANDA - Specjalist. Gabinety Lekarskie | Krakow, 31-156, Poland |
Completed | Centrum Badan Klinicznych PI-House | Gdansk, 80-546, Poland |
Withdrawn | Twoja Przychodnia-Centrum Medyczne Nowa Sol | Nowa 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 Center | Göteborg, 413 45, Sweden |
Completed | Kolding Sygehus | Kolding, 6000, Denmark |
Withdrawn | Sykehuset Innlandet HF Hamar | Hamar, 2326, Norway |
Terminated | Oslo universitetssykehus HF, Aker | Oslo, 0586, Norway |
Terminated | AKTIMED Helse AS | Hamar, 2317, Norway |
Terminated | Oslo Universitetssykehus HF, Ullevål | Oslo, 0450, Norway |
Terminated | Diabetologicka a endokrinologicka ambulance, Milan Kvapil | Praha 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.o | Chocen, 565 01, Czechia |
Withdrawn | ClinDiab Kft. | Budapest, 1089, Hungary |
Completed | COROMED SMO KFT | Pecs, 7623, Hungary |
Withdrawn | Belinus Bt. | Debrecen, 4025, Hungary |
Withdrawn | SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont | Szeged, 6720, Hungary |
Withdrawn | Kanizsai Dorottya Hospital | Nagykanizsa, 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 Stodolu | Liptovsky Mikulas, 03123, Slovakia |
Terminated | Tatratrial s. r. o. | Roznava, 04801, Slovakia |
Terminated | NEURES, s.r.o. | Krompachy, 053 42, Slovakia |
Terminated | Hopital Ambroise Pare | Boulogne billancourt, 92104, France |
Withdrawn | Cochin - Paris | PARIS, 75674, France |
Terminated | Hopital Carémeau - Nîmes | NIMES cedex 9, 30029, France |
Terminated | Hôpital François Mitterrand - Dijon | DIJON, 21000, France |
Terminated | Hôpital Lariboisière - Paris | PARIS, 75475, France |
Terminated | emovis GmbH | Berlin, 10629, Germany |
Terminated | Medamed Studienambulanz GmbH | Leipzig, 04315, Germany |
Terminated | Tampereen yliopistollinen sairaala, keskussairaala | Tampere, 33520, Finland |
Terminated | Turun yliopistollinen keskussairaala | Turku, 20520, Finland |
Terminated | Health Step Finland Oy | Kuopio, 70100, Finland |
Terminated | Diagnos Klaukkalan Lääkäriasema | Klaukkala, 01800, Finland |
Withdrawn | PRAGLANDIA | Praha 5, 150 00, Czechia |
Withdrawn | VFN, Fakultni poliklinika | Praha 2, 128 08, Czechia |
Withdrawn | Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice | Pardubice, 530 03, Czechia |
Withdrawn | DPCKh Orszagos Hematologiai es Infektologiai Intezet | Budapest, 1097, Hungary |
Withdrawn | Obudai Egeszsegugyi Centrum | Budapest, 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 Nitra | Nitra, 949 01, Slovakia |
Withdrawn | Osaka General Medical Center | Osaka, 558-8558, Japan |
Withdrawn | Meitetsu Hospital | Nagoya, 451-8511, Japan |
Withdrawn | Dokkyo Medical University Hospital | Shimotsuga-gun, 321-0293, Japan |
Withdrawn | Japan Red Cross Society Azumino Hospital | Azumino, 399-8292, Japan |
Withdrawn | Jiyugaoka YAMADA Clinic | Obihiro, 080-0848, Japan |
Withdrawn | Seino Internal Medicine Clinic | Koriyama, 963-8851, Japan |
Withdrawn | Saiki Central Hospital | Saiki, 876-0851, Japan |
Withdrawn | Kyosokai AMC NISHI-UMEDA Clinic | Osaka, 530-0001, Japan |
Withdrawn | Nakakinen Clinic | Naka, 311-0113, Japan |
Withdrawn | Fukuoka Wajiro Hospital | Fukuoka, 811-0213, Japan |
Withdrawn | Kagoshima University Hospital | Kagoshima, 890-8520, Japan |
Withdrawn | Otsu City Hospital | Otsu, 520-0804, Japan |
Withdrawn | Nakayama Clinic | Nagoya, 456-0058, Japan |
Withdrawn | Asahikawa City Hospital | Asahikawa, 070-8610, Japan |
Withdrawn | Nagano Municipal Hospital | Nagano, 381-8551, Japan |
Withdrawn | Yokohama City Minato Red Cross Hospital | Yokohama, 231-8682, Japan |
Withdrawn | Kunisaki Makoto Clinic | Fukuoka, 819-0168, Japan |
Withdrawn | JCHO Shimonoseki Medical Center | Shimonoseki, 750-0061, Japan |
Withdrawn | Hôpital Gabriel Montpied - Clermont Ferrand | CLERMONT FERRAND, 63000, France |
Withdrawn | Avdelningen för kliniska prövningar AKP | Örebro, 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 interventionNRS 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 interventionNRS 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 interventionThe 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 interventionThe 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
7