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 Pain
Sponsor study identifier
interventional
193
3 countries
20
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)Study Completion
January 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 26, 2007
Actual (reported)March 27, 2007
Actual (reported)May 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 2007
Actual (reported)January 2008
Actual (reported)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
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
Capsules containing 7 mg BVT.115959 administered orally three times daily
Placebo capsules administered orally three times daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Biovitrum investigational site
České Budějovice, Czechia
Biovitrum investigational site
Litoměřice, Czechia
Biovitrum investigational site
Pilsen, Czechia
Biovitrum investigational site
Prague, Czechia
Biovitrum Investigational Site
Bad Kreuznach, Germany
Biovitrum Investigational Site
Berlin, Germany
Biovitrum Investigational Site
Dortmund, Germany
Keith Bragman, MD FRCP FRCPath FFPM
Swedish Orphan Biovitrum
193 participants (actual enrollment reported by the registry).
First Submitted
March 26, 2007
First Posted
March 27, 2007
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Biovitrum Investigational Site
Gelsenkirchen, Germany
Biovitrum Investigational Site
Hamburg, Germany
Biovitrum Investigational Site
Mainz, Germany
Biovitrum Investigational Site
Mannheim, Germany
Biovitrum Investigational Site
Neumünster, Germany
Biovitrum Investigational Site
Bloemfontein, South Africa
Biovitrum Investigational Site
Durban, South Africa
Biovitrum Investigational Site
Kenilworth, South Africa
Biovitrum Investigational Site
Kraaifontein, South Africa
Biovitrum Investigational Site
Polokwane, South Africa
Biovitrum Investigational Site
Pretoria, South Africa
Biovitrum Investigational Site
Somerset West, South Africa
Biovitrum Investigational Site
Wynberg, South Africa
Primary Completion
December 2007
Actual (reported)Study Completion
January 2008
Actual (reported)Last Updated
November 3, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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