Diabetic Neuropathic Pain
Conditions
Interventions
Product Name: BVT.115959
Product Code: BVT.115959
Pharmaceutical Form: Capsule*
Current Sponsor code: BVT.115959
Other descriptive name: 6-Amino-2-methoxy-9-ß-D-ribofuranosylpurine hemihydrate, 2-meth
Sponsors
Biovitrum AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged 18 years or older 2.A diagnosis of type 1 or type 2 diabetes mellitus and documented distal and bilateral sensory polyneuropathy for at least 6 months prior to randomization. Pain must have begun in the feet with a relatively symmetric onset 3.Female patients will be either post-menopausal (i.e., 12 months since last menstruation) or surgically sterile 4.An average 24-hour pain intensity score =4 on an 11-point Likert NRS completed upon awakening on at least 5 out of 7 days during the 1 week baseline period 5.A score =40 mm on the VAS of the SF-MPQ at both the screening and randomization visits 6.The quality of pain must be burning (of at least 1 hour’s duration each day) and/or lancinating, sharp or throbbing pain which significantly affects quality of life or interferes with normal behaviour 7.On standard, stable anti-diabetic medication for at least 4 weeks prior to randomization 8.Glycolsylated hemoglobin =10% during the 1-week baseline period. Stable qlycemic control should be assessed by a physician investigator 9.Either no analgesic medication or stable analgesic medication for at least 4 weeks prior to randomization. Treatment may include simple analgesia (including over the counter medicines) and/or peripherally and/or centrally acting prescribed drugs 10.None or stable, alcohol intake for at least 4 weeks prior to randomization 11.Signed informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Female patients who are fertile and of child bearing potential 2.Use of herbal or natural remedies which are undefined and thought to have analgesic and anti inflammatory properties within 4 weeks prior to randomization 3.An estimated creatinine clearance (CrCl) 1.25 times the upper limit of normal of the laboratory range. A serum creatinine value or a CrCl value obtained in the month prior to randomization will be acceptable unless the investigator believes that there may have been a change in renal function. If this is the case, the investigator should obtain a new estimate of renal function 4.Clinically significant or unstable hepatic, respiratory, renal, hematologic, cardiovascular or peripheral vascular disease which in the opinion of the investigator should preclude study entry and the ability of the patient to successfully complete the study, i.e., a patient meeting the criteria for grade IV or grade V according to the American Society of Anesthesiologists Physical Status Classification* *Grade I: normal healthy individual; Grade II: mild systemic disease that does not limit activity; Grade III: severe systemic disease that limits activity but is not incapacitating; Grade IV: a patient with incapacitating systemic disease that is a constant threat to life; Grade V: a moribund patient who is not expected to survive 24 hours with or without operation 5.Other painful conditions that may confound the evaluation of neuropathic pain, e.g., pain related to trigeminal neuralgia, spinal cord injury, central post stroke pain, multiple sclerosis related pain, chronic spinal axis pain with radiculopathy, complex regional pain syndrome I and II, peripheral ischemic pain at rest (pain on exercise should be differentiated and would be allowable regarding study entry) 6.Radiotherapy in the 3 months prior to study entry 7.Herpes zoster in the preceding 6 months and/or coincidental postherpetic neuropathic pain 8.Neurosurgical procedure or an invasive procedure for pain management e.g., continuing stimulation of the dorsal root ganglion or sympathectomy in the 3 months prior to study entry. Not including simple intramuscular or intravenous injection 9.Amputations other than toes 10.Suspected or known drug or alcohol abuse, where alcohol abuse is defined as more than 14 or 21 units per week for women and men, respectively 11.Suspected or known allergy to any components of the study treatments 12.Documented human immunodeficiency virus infection 13.Enrollment in another concurrent investigational study or intake of investigational drug within the previous 3 months 14.Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion in the study 15.Failure to cooperate with given instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the analgesic properties of BVT.115959 in subjects with diabetic neuropathic pain against placebo following 4 weeks’ treatment.;Secondary Objective: •To evaluate the effect of BVT.115959 on additional pain assessments. •To evaluate the effect of BVT.115959 on sleep disturbance related to neuropathic pain. •To evaluate the effect of BVT.115959 on quality of life and mood stability. •To evaluate the effect of BVT.115959 on time to withdrawal for subjects experiencing unacceptable pain or discomfort. •To evaluate the tolerability of BVT.115959 against placebo by monitoring adverse events (AEs), including cardiovascular side effects and effects on clinical laboratory parameters. •To evaluate the plasma concentration of BVT.115959 through plasma sampling and to relate plasma drug concentrations to AEs (including any cardiovascular dynamic changes, AEs, or laboratory abnormalities) in a sub population. ;Primary end point(s): The primary efficacy endpoint is the change in mean 24-hour pain intensity score for Week 4 (weekly mean) or the last week of treatment from baseline (Visit 2 / Randomization) using an 11 point Likert numerical rating scale (NRS) ranging from 0 (No pain) to 10 (Worst imaginable pain) assessed over the preceding 24 hours immediately upon awakening in the morning, prior to the morning drug administration | — |
Countries
Czech Republic, Germany, United Kingdom
Outcome results
None listed