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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
154
Tablet, intake orally.
Tablet, intake orally.
Capsule, intake orally.
Capsule, intake orally. Starting dose 75 mg BID first week, increase to 150 mg BID in second week.
NEUROHK s.r.o
Choceň, Czechia
Clintrial s.r.o.
Prague, Czechia
Diabet2, s.r.o.
Prague, Czechia
Diabetologicka a endokrinologicka ambulance, Milan Kvapil
Prague, Czechia
Diabetologicka a endokrinologicka ambulance, Milan Kvapil,
Příbram, Czechia
Vestra Clinics s.r.o.
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".
Time 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".
Time frame: Part B: from baseline to end of intervention (in total up to 13 weeks)
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.
Time 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").
Time 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)
Time 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)
Time frame: Start of intervention to 14 days after stop of treatment
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Rychnov nad Kněžnou, Czechia
Aalborg Universitetshospital
Aalborg, Denmark
Steno Diabetes Center Copenhagen
Herlev, Denmark
Holbæk Sygehus
Holbæk, Denmark
Kolding Sygehus
Kolding, Denmark
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