Status:
COMPLETED
Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Diabetic Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT00452777
Start Date
May 1 2007
End Date
January 1 2008
Last Update
November 3 2014
Active Locations (20)
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1
Biovitrum investigational site
České Budějovice, Czechia
2
Biovitrum investigational site
Litoměřice, Czechia
3
Biovitrum investigational site
Pilsen, Czechia
4
Biovitrum investigational site
Prague, Czechia