A double-blind, placebo-controlled, randomized, parallel-group study evaluating the efficacy and tolerability of oral BVT.115959, a novel A2A agonist, versus placebo in the treatment of diabetic neuropathic pai

• Conditions: Diabetic Neuropathic Pain

• Registration Number: EUCTR2006-005967-25-CZ
• Lead Sponsor: Biovitrum AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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

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) <60 mL/min (calculated from serum creatinine using the Cockcroft-Gault formula) and serum creatinine >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified