Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452777
Status:
COMPLETED
Last Update Posted:
2014-11-02
First Post:
2007-03-26
Brief Title:
Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain
Sponsor:
Swedish Orphan Biovitrum
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
A Double-blind Placebo-controlled Randomized Parallel-group Study Evaluating the Efficacy and Tolerability of Oral BVT115959 a Novel A2A Agonist Versus Placebo in the Treatment of Diabetic Neuropathic Pain
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and tolerability of BVT115959 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 BVT115959 in the reduction of the symptoms of pain Thus the primary objective is to evaluate the anticipated analgesic properties of BVT115959 in patients with diabetic neuropathic pain and to confirm its activity against placebo
The study will evaluate the efficacy and tolerability of oral BVT115959 7 mg administered three times a day tid 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 21 BVT115959 placebo
The study consists of a 1-week screeningbaseline period a 4-week treatment period and a 1 week follow-up period
The study will evaluate the efficacy and tolerability of oral BVT115959 7 mg administered three times a day tid 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 21 BVT115959 placebo
The study consists of a 1-week screeningbaseline period a 4-week treatment period and a 1 week follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None