Diabetic Neuropathic Pain
Conditions
Keywords
Diabetic neuropathy, painful, Adenosine A2A receptor
Brief summary
The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.
Detailed description
The planned study is an exploratory study which aims to provide proof of the efficacy of BVT.115959 in the reduction of the symptoms of pain. Thus, the primary objective is to evaluate the anticipated analgesic properties of BVT.115959 in patients with diabetic neuropathic pain and to confirm its activity against placebo. The study will evaluate the efficacy and tolerability of oral BVT.115959 7 mg administered three times a day (t.i.d.) versus a matching placebo in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study and who are being maintained on stable analgesia throughout the study. Eligible subjects will be randomized in a ratio of 2:1 (BVT.115959: placebo). The study consists of a 1-week screening/baseline period, a 4-week treatment period and a 1 week follow-up period.
Interventions
DRUGBVT.115959
DRUGPlacebo
Sponsors
Swedish Orphan Biovitrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of type 1 or 2 diabetes mellitus and documented painful, symmetrical, sensorimotor polyneuropathy for at least 6 months * Either no analgesic medication or on stable analgesic medication for at least 4 weeks
Exclusion criteria
* Female patients who are fertile and of child-bearing potential * Clinically significant or unstable hepatic, respiratory, renal, hematologic, cardiovascular or peripheral vascular disease * Painful conditions that may confound the evaluation of neuropathic pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean 24-hour pain intensity score from baseline using an 11-point Likert NRS assessed over the preceding 24 hours immediately upon awakening in the morning | — |
Secondary
| Measure | Time frame |
|---|---|
| Present pain intensity using an 11-point Likert NRS assessed at bedtime | — |
| Short-Form McGill Pain Questionnaire parameters | — |
| Weekly mean sleep interference score | — |
| Clinical Global Impression of Change and Patient's Global Impression of Change | — |
| Quality of life | — |
| Mood stability | — |
| Time to study withdrawal | — |
Countries
Czechia, Germany, South Africa
Outcome results
None listed